Negative pressure wound closure device

ABSTRACT

The present invention relates to wound closure devices, systems and methods. Embodiments of the invention facilitate closure of the wound by preferentially contracting under negative pressure to provide for movement of the surrounding tissues. Some embodiments may utilize tissue securing portions that aid in securing the invention within a wound.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a national stage application of International PatentApplication No. PCT/US2016/029888, filed on Apr. 28, 2016, which claimsthe benefit of U.S. Provisional Application No. 62/154,609, filed Apr.29, 2015, entitled NEGATIVE PRESSURE WOUND CLOSURE DEVICE. The contentof the aforementioned applications is hereby incorporated by referencein its entirety as if fully set forth herein. The benefit of priority tothe foregoing applications is claimed under the appropriate legal basis,including, without limitation, under 35 U.S.C. § 119(e).

BACKGROUND OF THE INVENTION Field of the Invention

This application describes embodiments of apparatuses, methods, andsystems for the treatment of wounds, specifically to aid in the closureof large wounds, in conjunction with the administration of negativepressure.

Description of the Related Art

Negative pressure wound therapy has been used in the treatment ofwounds, and in many cases can improve the rate of healing while alsoremoving exudates and other deleterious substances from the wound site.

Abdominal compartment syndrome is caused by fluid accumulation in theperitoneal space due to edema and other such causes, and results ingreatly increased intra-abdominal pressure that may cause organ failureeventually resulting in death. Causes may include sepsis or severetrauma. Treatment of abdominal compartment syndrome may require anabdominal incision to permit decompression of the abdominal space, andas such, a large wound may be created onto the patient. Closure of thiswound, while minimizing the risk of secondary infections and othercomplications, and after the underlying edema has subsided, then becomesa priority. However, acute open abdominal conditions may be caused byother reasons in addition to compartment syndrome, as described furtherbelow.

Other large or incisional wounds, either as a result of surgery, trauma,or other conditions, may also require closure. For example, woundsresulting from sterniotomies, fasciotomies, and other abdominal woundsmay require closure. Wound dehiscence of existing wounds is anothercomplication that may arise, possibly due to incomplete underlyingfascial closure, or secondary factors such as infection.

Existing negative pressure treatment systems, while permitting eventualwound closure, still require lengthy closure times. Although these maybe combined with other tissue securement means, such as sutures, thereis also a risk that underlying muscular and fascial tissue is notappropriately reapproximated so as to permit complete wound closure.Further, when foam or other wound fillers are inserted into the wound,the application of negative pressure to the wound and the foam may causeatmospheric pressure to bear down onto the wound, compressing the foamdownward and outward against the margins of the wound. This downwardcompression of the wound filler slows the healing process and slows orprevents the joining of wound margins. Additionally, inflammation of thefascia in the form of certain types of fasciitis can lead to rapid andexcessive tissue loss, potentially meriting the need for more advancednegative pressure treatment systems. Accordingly, there is a need toprovide for an improved apparatus, method, and system for the treatmentand closure of wounds.

SUMMARY OF THE INVENTION

Embodiments of the present invention relate to negative pressure woundclosure devices, methods, and systems that facilitate closure of awound. It will be understood by one of skill in the art that the woundsdescribed herein this specification may encompass any wound, and are notlimited to a particular location or type of wound. The devices, methods,and systems may operate to reduce the need for repetitive replacement ofwound filler material currently employed and can advance the rate ofhealing. The devices, methods, and systems may be simultaneously usedwith negative pressure to remove wound fluids.

In embodiments, an apparatus for treating a wound with negative pressurewound therapy, comprises:

-   -   a stabilizing structure having an oculiform shape for insertion        into a wound, the stabilizing structure configured to collapse        more in a horizontal plane parallel to a length and a width of        the stabilizing structure than in a vertical plane perpendicular        to the horizontal plane.

The stabilizing structure may comprise two extended sections extendingin opposite directions along a longitudinal axis of the stabilizingstructure. The extended sections can comprise a stepped shaped. In someembodiments, the stabilizing structure comprises a plurality of cells.The extended sections may comprise a plurality of rows of cells. Inparticular embodiments, the extended sections comprise a first rowcomprising four cells, a second row comprising two cells, and a thirdrow comprising two cells. In some embodiments, the apparatus maycomprise a plurality of tabs extending outward from the outer wall. Thetabs may comprise a surgical adhesive and/or the tabs may compriseanchors configured to grip foam. In certain embodiments, the apparatuscomprises a first bottom layer of foam attached to a bottom of thestabilizing structure. The first bottom layer of foam may comprise a lipthat extends outward to extend into surrounding tissue. In certainembodiments, the apparatus further comprises a top layer of foamattached to a top of the stabilizing structure. The apparatus maycomprise a second bottom layer of foam attached to the bottom layer offoam. The second bottom layer of foam can comprise a lip that extendsoutward from the stabilizing structure for positioning beneath a fascialayer. In embodiments, the foam layers are attached to a plurality oftabs extending from the outer wall of the stabilizing structure. Incertain embodiments, at least one of the foam layers comprise printedsymbols, the symbols comprising arrows indicating the proper positioningof the foam layer within the wound.

In some embodiments, a wound closure device comprises:

-   -   a stabilizing structure for insertion into a wound; and    -   a plurality of stabilizing clips connected by a plurality of        linkers, the plurality of stabilizing clips attachable to an        outer wall of the stabilizing structure, the stabilizing clips        configured to extend outward into surrounding tissue and prevent        the stabilizing structure from lifting upwards in a direction        out of the wound.

The stabilizing structure may be configured to collapse more in ahorizontal plane parallel to a length and a width of the stabilizingstructure than in a vertical plane perpendicular to the horizontalplane. In certain embodiments, the stabilizing clips comprise anattachment portion configured to clip to a wall of the stabilizingstructure and a securing portion that extends outward from theattachment portion in a horizontal direction. The securing portions maycomprise a plurality of grippers. In embodiments, the stabilizing clipscan comprise a recess where the securing portion extends from theattachment portion. The attachment portion may be configured to loopover the outer wall of the stabilizing structure, wherein the attachmentportion comprises a foot at an end of the loop of the attachmentportion. In some embodiments, the securing portion may comprise grippersconfigured to extend into the surrounding tissue. The linkers maycomprise string. In certain embodiments, the stabilizing structure mayhave an oculiform shape and/or an elliptical shape and/or a diamondshape.

In embodiments, a wound closure device may comprise:

-   -   a stabilizing structure for insertion into a wound;    -   a top layer of foam attached to a top of the stabilizing        structure, the top layer of foam conforming to the shape of the        stabilizing structure;    -   a middle layer of foam attached to a bottom of the stabilizing        structure, the middle layer of foam conforming to the shape of        the stabilizing structure; and    -   a bottom layer of foam, the bottom layer of foam attached to the        middle layer of foam, the bottom layer of foam comprising a lip        that extends outward into the surrounding tissue of the wound.        In certain embodiments, the stabilizing structure may have an        oculiform shape.

In some embodiments, a method of treating a wound comprises:

-   -   providing a stabilizing structure;    -   attaching a top layer of foam to the stabilizing structure;    -   attaching a bottom layer of foam to the stabilizing structure,        the bottom layer of foam comprising a lip extending outward into        the surrounding tissue; and    -   inserting the stabilizing structure into the wound, wherein        after insertion the lip engages tissue to prevent the        stabilizing structure from lifting upwards in a direction out of        the wound.

The method may further comprise:

-   -   covering the stabilizing structure with at least one drape        sealed to skin surrounding the wound; and    -   applying negative pressure through the at least one drape to the        wound via a source of negative pressure, wherein the application        of negative pressure causes the stabilizing structure to        horizontally collapse.

The method can also further comprise inserting a tissue protection layerover the wound before inserting the stabilizing structure. The bottomlayer of foam may be wider than the top layer of foam. The stabilizingstructure may have an oculiform shape.

Other embodiments of wound closure devices, stabilizing structures andassociated apparatuses are described below.

BRIEF DESCRIPTION OF THE DRAWINGS

Other features and advantages of the present invention will be apparentfrom the following detailed description of the invention, taken inconjunction with the accompanying drawings of which:

FIG. 1 illustrates an embodiment of a negative pressure treatmentsystem.

FIGS. 2A-C illustrate multiple views of an embodiment of a stabilizingstructure.

FIGS. 3A-E illustrate multiple views of another embodiment of astabilizing structure and a method of creating the stabilizingstructure.

FIG. 4 illustrates an embodiment of a ring that can surround astabilizing structure.

FIGS. 5A-D are photographs of embodiments of stabilizing structures withsurrounding anchoring and foam layers.

FIGS. 6A-B are photographs of an embodiment of an anchoring layer.

FIG. 7 illustrates an embodiment of an open abdominal wound.

FIG. 8 illustrates an embodiment of a step in a method of treating awound.

FIG. 9 illustrates an embodiment of a step in a method of treating awound.

FIGS. 10A-C illustrate an embodiment of steps of a method of treating awound.

FIGS. 11A-B are photographs of steps of a method of treating a wound.

FIGS. 12A-C depict an embodiment of steps of a method of treating awound.

FIG. 13 contains photographs of embodiments of steps of a method oftreating a wound.

FIGS. 14A-G illustrate an embodiment of a method of treating a wound.

FIG. 15A-E are photographs of an embodiment of a method of treating awound.

FIG. 16 illustrates an embodiment of a stabilizing structure.

FIGS. 17A-E are drawings and photographs of an embodiment of astabilizing structure.

FIGS. 18A-D illustrate an embodiment of a collapsed stabilizingstructure.

FIGS. 19A-B illustrate embodiments of stabilizing structures.

FIGS. 20A-G illustrate embodiments of stabilizing structures and foamlayers.

FIG. 21 illustrates an embodiment of a foam layer with fingers.

FIGS. 22A-E illustrate embodiments of a foam layer with printing.

FIGS. 23A-F are drawings and photographs of stabilizing clips forattachment to a stabilizing structure.

FIGS. 24A-G are photographs and illustrations of embodiments of anelliptical stabilizing structure with attached stabilizing clips.

FIGS. 25A-G illustrate embodiments of stabilizing clips with grippers.

FIGS. 26A-J illustrate embodiments of stabilizing clips for attachmentto a stabilizing structure with a step or recess at the intersection ofthe securing portion and the attachment portion.

FIGS. 27A-J illustrate embodiments of stabilizing clips for attachmentto a stabilizing structures with a foot.

FIGS. 28A-E illustrate embodiments of a stabilizing device forattachment to a stabilizing structure.

FIGS. 29A-E illustrate embodiments of stabilizing clips for attachmentto a stabilizing structure.

FIGS. 30A-B illustrate embodiments of stabilizing clips for attachmentto a stabilizing structure.

FIGS. 31A-H illustrate embodiments of stabilizing clips attachedtogether by linkers.

FIGS. 32A-B present experimental data collected using embodiments ofstabilizing structures and wound closure devices.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Embodiments disclosed in this section or elsewhere in this specificationrelate to apparatuses and methods of treating a wound with reducedpressure, including pump and wound dressing components and apparatuses.The apparatuses and components comprising the wound overlay and packingmaterials, if any, are sometimes collectively referred to in thissection or elsewhere in this specification as dressings.

It will be appreciated that throughout this specification reference ismade to a wound. It is to be understood that the term wound is to bebroadly construed and encompasses open and closed wounds in which skinis torn, cut or punctured or where trauma causes a contusion, or anyother superficial or other conditions or imperfections on the skin of apatient or otherwise that benefit from reduced pressure treatment. Awound is thus broadly defined as any damaged region of tissue wherefluid may or may not be produced. Examples of such wounds include, butare not limited to, abdominal wounds or other large or incisionalwounds, either as a result of surgery, trauma, sterniotomies,fasciotomies, or other conditions, dehisced wounds, acute wounds,chronic wounds, subacute and dehisced wounds, traumatic wounds, flapsand skin grafts, lacerations, abrasions, contusions, burns, electricalburns, diabetic ulcers, pressure ulcers, stoma, surgical wounds, traumaand venous ulcers or the like.

As is used in this section or elsewhere in this specification, reducedor negative pressure levels, such as −X mmHg, represent pressure levelsthat are below standard atmospheric pressure, which corresponds to 760mmHg (or 1 atm, 29.93 inHg, 101.325 kPa, 14.696 psi, etc.). Accordingly,a negative pressure value of −X mmHg reflects absolute pressure that isX mmHg below 760 mmHg or, in other words, an absolute pressure of(760−X) mmHg. In addition, negative pressure that is “less” or “smaller”than −X mmHg corresponds to pressure that is closer to atmosphericpressure (e.g., −40 mmHg is less than −60 mmHg). Negative pressure thatis “more” or “greater” than −X mmHg corresponds to pressure that isfurther from atmospheric pressure (e.g., −80 mmHg is more than −60mmHg).

The negative pressure range for some embodiments of the presentdisclosure can be approximately −80 mmHg, or between about −10 mmHg and−200 mmHg. Note that these pressures are relative to normal ambientatmospheric pressure. Thus, −200 mmHg would be about 560 mmHg inpractical terms. In some embodiments, the pressure range can be betweenabout −40 mmHg and −150 mmHg. Alternatively, a pressure range of up to−75 mmHg, up to −80 mmHg or over −80 mmHg can be used. Also in otherembodiments a pressure range of below −75 mmHg can be used.Alternatively, a pressure range of over approximately −100 mmHg, or even−150 mmHg, can be supplied by the negative pressure apparatus. In someembodiments, the negative pressure range can be as small as about −20mmHg or about −25 mmHg, which may be useful to reduce fistulas. In someembodiments of wound closure devices described here, increased woundcontraction can lead to increased tissue expansion in the surroundingwound tissue. This effect may be increased by varying the force appliedto the tissue, for example by varying the negative pressure applied tothe wound over time, possibly in conjunction with increased tensileforces applied to the wound via embodiments of the wound closuredevices. In some embodiments, negative pressure may be varied over timefor example using a sinusoidal wave, square wave, and/or insynchronization with one or more patient physiological indices (e.g.,heartbeat).

Examples of such applications where additional disclosure relating tothe preceding descriptions may be found include U.S. Pat. No. 8,235,955,titled “Wound treatment apparatus and method,” issued Aug. 7, 2012 andU.S. Pat. No. 7,753,894, titled “Wound cleansing apparatus with stress,”issued Jul. 13, 2010. Both applications are hereby incorporated byreference in their entirety. Other applications that may containteachings relevant for use with the embodiments described in thissection or elsewhere in this specification may include application Ser.No. 12/886,088, titled “Systems And Methods For Using Negative PressureWound Therapy To Manage Open Abdominal Wounds,” filed Sep. 20, 2010,published as US 2011/0213287; application Ser. No. 13/092,042, titled“Wound Dressing And Method Of Use,” filed Apr. 21, 2011, published as US2011/0282309; and application Ser. No. 13/365,615, titled “NegativePressure Wound Closure Device,” filed Feb. 3, 2012, published as US2012/0209227, the entireties of each of which are hereby incorporated byreference. Still more applications that may contain teachings relevantfor use with the embodiments described in this specification areapplication Ser. No. 13/942,493, titled “Negative Pressure Wound ClosureDevice,” filed Jul. 15, 2013, published as US 2014/0180225; PCT App. No.PCT/US2013/050619, filed Jul. 16, 2013 titled “Negative Pressure WoundClosure Device,” published as WO 2014/014871 A1; PCT App. No.PCT/US2013/050698, filed Jul. 16, 2013 titled “Negative Pressure WoundClosure Device,” published as WO 2014/014922 A1; PCT App. No.PCT/M2013/01555, titled “Devices and Methods for Treating and ClosingWounds with Negative Pressure,” filed May 5, 2013, published as WO2013/175309 A1; PCT App. No. PCT/US2014/025059, titled “NegativePressure Wound Closure Device and Systems and Methods of Use in TreatingWounds with Negative Pressure,” filed Mar. 12, 2014, published as WO2014/165275 A1; and PCT App. No. PCT/GB2014/050746, “Compressible WoundFillers and Systems and Methods of Use In Treating Wounds With NegativePressure,” filed Mar. 13, 2014, published as WO 2014/140578 A1, and“Negative Pressure Wound Closure Device,” filed Oct. 21, 2014, andpublished as PCT/US2014/061627. The entireties of the aforementionedapplications are each hereby incorporated by reference and should beconsidered part of the present specification.

It will be understood that throughout this specification in someembodiments reference is made to an elongate, elongated or longitudinalstrip or strips. It is to be understood that these terms are to bebroadly construed and refer in some embodiments to an elongate materialhaving two parallel or substantially parallel faces, where incross-section a thickness of the material as measured perpendicular tothe faces is relatively smaller than a height of the material measuredparallel to the faces. While in some embodiments the strips may beconstructed from discrete lengths of material, in other embodiments thestrips may simply refer to elongate portions of an overall structurehaving two parallel or substantially parallel faces. The strips in someembodiments have a rectangular or generally rectangular-shaped faces,wherein a length of the face is longer than the height of the face. Insome embodiments, the length of the face may be more than 2 times, 4times, 6 times, 8 time, 10 times, 12 times or more greater than theheight of the face.

As used in this section or elsewhere in this specification, the term“horizontal,” when referring to a wound, indicates a direction or planegenerally parallel to the skin surrounding the wound. The term“vertical,” when referring to a wound, generally refers to a directionextending perpendicular to the horizontal plane. The term“longitudinal,” when referring to a wound, generally refers to adirection in the horizontal plane taken in a direction along which thewound is longest. The term “lateral,” when referring to a wound,generally refers to a direction in the horizontal plane perpendicular tothe longitudinal direction. The terms “horizontal,” “vertical,”“longitudinal,” and “lateral” may also be used to describe thestabilizing structures and wound closure devices described throughoutthis specification. When describing these structures or devices, theseterms should not be construed to require that the structures or devicesnecessarily be placed into a wound in a certain orientation, though incertain embodiments, it may be preferable to do so.

FIG. 1 illustrates an embodiment of a negative pressure treatment system100 that comprises a wound packer 102 inserted into a wound 101. Thewound packer 102 may comprise porous materials such as foam, and in someembodiments may comprise one or more embodiments of wound closuredevices described in further detail in this section or elsewhere in thisspecification. In some embodiments, the perimeter or top of any woundclosure device inserted into the wound 101 may also be covered with foamor other porous materials. A single drape 104 or multiple drapes may beplaced over the wound 101, and is preferably adhered or sealed to theskin on the periphery of the wound 101 so as to create a fluid-tightseal. An aperture 106 may be made through the drape 104 which can bemanually made or preformed into the drape 104 so as to provide a fluidicconnection from the wound 101 to a source of negative pressure such as apump 110. Preferably, the fluidic connection between the aperture 106and the pump 110 is made via a conduit 108. In some embodiments, theconduit 108 may comprise a RENASYS® Soft Port™, manufactured by Smith &Nephew. Of course, in some embodiments, the drape 104 may notnecessarily comprise an aperture 106, and the fluidic connection to thepump 110 may be made by placing the conduit 108 below the drape. In somewounds, particularly larger wounds, multiple conduits 108 may be used,fluidically connected via one or more apertures 106.

In some embodiments, the drape 104 may be provided with one or morecorrugations or folds. Preferably, the corrugations are aligned alongthe longitudinal axis of the wound, and as such may support closure ofthe wound by preferentially collapsing in a direction perpendicular tothe longitudinal axis of the wound. Such corrugations may aid in theapplication of contractile forces parallel to the wound surface and inthe direction of wound closure. Examples of such drapes may be found inapplication Ser. No. 12/922,118, titled “Vacuum Closure Device,” filedNov. 17, 2010 (published as US 2011/0054365), which is herebyincorporated by reference in its entirety.

In use, the wound 101 is prepared and cleaned. In some cases, such asabdominal wounds, a non- or minimally-adherent organ protection layer(not illustrated) may be applied over any exposed viscera. The woundpacker 102 is then inserted into the wound, and is covered with thedrape 104 so as to form a fluid-tight seal. A first end of the conduit108 is then placed in fluidic communication with the wound, for examplevia the aperture 106. The second end of the conduit 108 is connected tothe pump 110. The pump 110 may then be activated so as to supplynegative pressure to the wound 101 and evacuate wound exudate from thewound 101. As will be described in additional detail below and inrelation to the embodiments of the foregoing wound closure devices,negative pressure may also aid in promoting closure of the wound 101,for example by approximating opposing wound margins.

Any structure or component disclosed herein this section or elsewhere inthe specification may comprise a radiopaque material. A radiopaquematerial advantageously allows a clinician to more easily find pieces ofthe wound closure device that may have come loose from the structure andbecome lost in the wound. Some examples of radiopaque materials includebarium sulfate, bismuth trioxide, bismuth subcarbonate, bismuthoxychloride, and tungsten.

Stabilizing Structures and Wound Closure Devices of FIG. 2A-3E

FIG. 2A is a drawing of an embodiment of a stabilizing structure 6000comprising a plurality of elongate strips 6006 arranged in parallel orsemi-parallel, whose longitudinal length can be aligned with thelongitudinal axis of a wound. In embodiments, the elongate strips 6006may also be arranged in a non-parallel fashion. The various cells withinthis stabilizing structure 6000 may have a variety of shapes and sizes.As will be described in greater detail below, the length and shape ofthe elongate strips 6006, intervening members 6010, and cells 6004 maybe designed so as to facilitate greater closure of the stabilizingstructure. In certain embodiments, the junctions 6900 between theelongate strips and intervening members may be thinned to betterfacilitate rotation and closure of the stabilizing structures. In someembodiments, the stabilizing structure is tearable, such that thestructure may be shaped into the shape of a wound. As describedelsewhere in the specification, tears may be completed at theintersections between intervening members and elongate strips or at anysuitable location along the elongate strip or intervening member.

All stabilizing structures described herein this section or elsewhere inthe specification may be fashioned to accommodate any size of wound.However, to better accommodate the needs of the clinical environment, incertain embodiments, the stabilizing structures described herein may beprovided in a pack of two sizes, one smaller stabilizing structure andone larger stabilizing structure about 1.25 times as larger, about 1.5times as large, about 1.75 times as large, about 2 times as larger,about 2.5 times as larger, about 3 times as large, about 4 times aslarge, about 5 times as large, or more than about 5 times as large. Insome embodiments, the pack may comprise more than two sizes, such asthree sizes, four sizes, five sizes, or more than five sizes. Thestabilizing structures within the pack may be of a variety of sizes inrelation to one another such as the ratios described above.

In certain embodiments, the stabilizing structure 6000 can collapse inany manner described in this section or elsewhere in this specificationwith or without the application of negative pressure. For example, thestabilizing structure may collapse significantly more in one plane thanin another plane upon application of negative pressure. In someembodiments, the stabilizing structure is configured to collapse more ina horizontal plane parallel to the length and width of the stabilizingstructure than in a vertical plane perpendicular to the horizontalplane. In embodiments, particular rows may collapse in a firstdirection, while another row may collapse in the same or an opposingdirection. In certain embodiments, the stabilizing structure maycollapse along the width of the stabilizing structure while remainingrelatively rigid along the length of the stabilizing structure and inthe vertical direction.

The stabilizing structure may be comprised of any materials described inthis section or elsewhere in this specification, including: flexibleplastics such as silicone, polyurethane, rigid plastics such aspolyvinyl chloride, semi-rigid plastics, semi-flexible plastics,biocompatible materials, composite materials, metals, and foam. Incertain embodiments, the stabilizing structure may comprise a radioopaque material, to more readily allow a clinician to find pieces of thestabilizing structure within the wound.

Returning to FIG. 2A, stabilizing structure 6000 may have an outerperimeter that defines an at least partially elliptical shape. Asdescribed above, stabilizing structure 6000 may comprise a plurality ofcells 6004 provided side-by-side, each cell defined by one or morewalls, each cell having a top end and a bottom end with an openingextending through the top and bottom ends. As with the other stabilizingstructures described herein this section and elsewhere in thespecification, the stabilizing structure 6000 is configured to collapseby collapsing one or more cells 6004. In some embodiments, the cells areall of the same approximate shape and size; however, in otherembodiments, the cells are of different shapes and sizes. In someembodiments, the stabilizing structures as described herein this sectionor elsewhere in the specification may be domed, such that the centralportion of the stabilizing structure bulges upward. For example, a lowerportion of the stabilizing structure may be concave, while an upperportion of the stabilizing structure is convex.

The elongate strips 6006 may be made from one single material, such asthose described elsewhere in the specification, or the elongate stripsmay be made from multiple materials. For example, elongate strips 6006may comprise sections of more rigid material and sections of moreflexible material. The elongate strips 6006 may be curved along theirlength so as to facilitate the curved outer perimeter of the stabilizingstructure 6000. The elongate strips may be curved along their lengthsoutward away from a center of the stabilizing structure 6000. The archof the curves of the elongate strips 6006 may vary considerably, withsome strips 6006 being highly curved while other are minimally curved oreven straight.

Similarly, the stabilizing structure 6000 can further comprise aplurality of intervening members 6010 connected to the elongate strips6006. The intervening members 6010 may all be of a similar shape andsize or they may be of a variety of shapes and sizes. The interveningmembers may be constructed from any material disclosed herein thissection or elsewhere in the specification. Further, the interveningmembers may be constructed from multiple materials.

Advantageously, the elliptical shape of stabilizing structure 6000 mayallow the structure to better accommodate the shape of the wound. Mostwounds are in shapes that are rounded, thus, an elliptically shapedstabilizing structure 6000 may better fit into a wound.

In embodiments, the outer perimeter 6002 may have a reduced edge 6012 soas to facilitate collapse of the stabilizing structure. By removing massof the stabilizing structure at reduced edge 6012, the stabilizingstructure can collapse more freely at reduced edge 6012, thus allowingfor a better fit within the wound. Further, by reduced the mass atreduced edge 6012, there may be less pinching of the surrounding tissueduring and after collapse of the stabilizing structure 6000.

The stabilizing structure 6000 and all stabilizing structures and woundclosure devices described in this section or elsewhere in thisspecification can collapse on a variety of timescales in a dynamicfashion. In certain embodiments, the majority of the collapse may occurwithin the first few minutes upon application of negative pressure.However, after the initial collapse, the stabilizing structure or woundclosure device may continue to collapse at a much slower rate, therebyapplying increasing longitudinal tension over a long period of time anddrawing the edges of the wound closer together. By slowly drawing thewound edges closer together over time, the stabilizing structure orwound closure device allows the surrounding healing tissue to remodelsynergistically with the closure of the device or stabilizing structure.Slow, dynamic wound closure may allow the surrounding tissue to heal atan accelerated rate, because the collapsing structure or device slowlybrings the edges of the wound closer together without stressing thenewly formed or weakened tissue too quickly.

In some embodiments, the stabilizing structures described in thissection or elsewhere in this specification can be placed into a woundfor a period of time and then removed or replaced with anotherstabilizing structure. For example, a stabilizing structure could beinserted into a wound for a period of time, promoting closure of thewound by drawing the edges closer together. After a period of time haspassed, the stabilizing structure can be replaced by a stabilizingstructure of a different size or collapsibility, for example astabilizing structure of a smaller size or decreased density. Thisprocess could be repeated over and over, thereby continuously drawingthe edges of the wound together over time and allowing for continuingrepair and remodeling of the surrounding tissue. In certain embodiments,the stabilizing structure is configured to remain in the wound for atleast about less than 1 hour, at least about 1 hour, at least about 2hours, at least about 4 hours, at least about 6 hours, at least about 8hours, at least about 12 hours, at least about 24 hours, at least about2 days, at least about 4 days, at least about 6 days, at least about 1week, at least about 2 weeks, at least about 3 weeks, or more than 3weeks.

In certain embodiments, up to 90% of the collapse of the stabilizingstructure or wound closure device may occur within the first few minutesupon application of negative pressure, while the remaining 10% of thecollapse may occur slowly over a period of many minutes, hours, days,weeks, or months. In other embodiments, up to about 80% of the collapse,up to about 70%, up to about 60%, up to about 50%, up to about 40%, upto about 30%, up to about 20%, up to about 10%, or about 0% of thecollapse will occur immediately within the first few minutes uponapplication of negative pressure while the remainder of the collapseoccurs at a much slower rate such as over the course of many minutes,hours, days weeks, or months. In other embodiments, the stabilizingstructure can collapse at a variable rate. In some embodiments, theentirety of the collapse occurs at a slowed rate, while in otherembodiments the entirety of the collapse occurs almost immediatelywithin the first few minutes. In further embodiments, the collapse canoccur at any rate and the rate can vary over time. In certainembodiments, the rate of collapse can be altered in a variable fashionby adding and/or removing portions of the structure or by controllingthe application of negative pressure and irrigant fluid.

Returning to FIG. 2A, in some embodiments, the pattern of thestabilizing structure 6000 is designed in such a way as to facilitatemaximum closure of the stabilizing structure. Preferably, maximumclosure is in a direction perpendicular to the length of the elongatemembers and within the horizontal plane. As will be described in greaterdetail below, greater closure may be achieved by varying the length ofthe elongate strips 6006, the length of the intervening members 6010,and the shape of the cells 6004. The shape of the cells 6004 maycomprise any shape described herein this section or elsewhere in thespecification. For example, as depicted in FIG. 2A, the cells 6004 maybe diamond-shaped or parallelepiped with smaller diamond-like shapes6020 located within larger diamonds 6022. Such a construction mayprovide greater overall closure of the stabilizing device 6000 toprovide for maximum closure of the wound. Additionally, the smallerdiamond-like shapes 6020 located within larger diamonds 6022 can spreadthe load over a greater area reducing the chance of damage to the tissuestructures below the matrix. This construction can also reduce thelikelihood of the foam or the drape being pulled into the matrix andpreventing closure of the wound.

FIGS. 2B-C are illustrations of different views of the stabilizingstructure embodiment of FIG. 2A. As described above in relation to FIG.2A, the stabilizing structure comprises cells 6004, intervening members6010, and elongate strips 6006; however, here a simulated shape of awound 6910 is also included for comparison.

Any of the stabilizing structures described herein this section orelsewhere in the specification may be constructed from any suitablemeans. For example, the stabilizing structures may be constructed viamolding or may be printed directly using 3D printing technology. Incertain embodiments, the stabilizing structures of FIGS. 2A-C may beconstructed from a single polymer via 3D printing. In some embodiments,the stabilizing structures may be constructed from one polymer, twopolymers, three polymers, or more than three polymers. The stabilizingstructures may be constructed from any material disclosed herein thissection or elsewhere in the specification. The stabilizing structure canbe made by cutting the structure out of a solid block of material.Methods used for cutting can include, for example, water jet cutting,laser cutting, or die cutting. The stabilizing structures may be cut tosize along the walls of the cells 6004. For example, the interveningmembers along the outside face of elongate strips 6006 can be cut off toappropriately size the stabilizing structure. The stabilizing structuremay be cut along the walls, along any portions of the elongate strips,and/or along any portions of the intervening members.

In some embodiments, the stabilizing structure 6000 of FIGS. 2A-C can beconfigured to include perforations or detachable sections that allowportions of the device to separate from the remainder of the device. Forexample, perforations may be incorporated into the joints 6900 betweenvarious cells 6004 contained within the stabilizing structure 6000,allowing for the removal of individual rows or cells to alter the shapeof the stabilizing structure 6000.

Applicable to all stabilizing structures or wound closure devicesdescribed in this section or elsewhere in the specification, thestabilizing structure or wound closure device may be tearable such thatthe stabilizing structure may be shaped into the shape of a wound. Insome embodiments, the stabilizing structure may be torn at theintersections between intervening members and elongate strips, while infurther embodiments, the elongate strips or intervening members may betorn at any suitable position.

FIGS. 3A-E depict methodologies for generating the design of astabilizing structure, such as the stabilizing structures of FIGS. 2A-C.To facilitate various types of closure (for example, maximum closure)the shape, size, and location of the elongate strips, interveningmembers, and cells may be determined via various methods. For example,as depicted in FIG. 3A, each collapsible cell 6030 has four sides, andeach intersection between an intervening member(s) and/or elongatedstrip(s) may be modeled via pin-joints 6032. Further, the entirety ofstabilizing structure 6034 may be modeled inside of an oval wound model6036. As depicted in FIG. 3A, the stabilizing structure 6034 may bemodeled to collapse from an open state 6038 to a semi-collapsed state6040, to a fully collapsed state 6042. In some clinical scenarios,maximum closure down to a completely flattened stabilizing structure maybe desirable to maximize wound closure by drawing the edges of the woundas close together as possible.

As illustrated in FIG. 3B, in certain embodiments, the process ofdetermining the optimal shape, size, and location of the elongatestrips, intervening members, and cells for wound closure may befacilitated by modeling the stabilizing structure as a mirrored patternon opposite sides of a mirror line 6050 (which may also be referred toas the transverse axis, perpendicular to a longitudinal axis of thestabilizing structure), thereby making the curve and collapse of thestabilizing structure symmetrical. The mirror axis may be along theminor axis or it may be along the major axis of the stabilizingstructure. Alternatively, the mirror line may be located in any suitablelocation within the stabilizing structure, such as diagonally across thestabilizing structure. In certain embodiments, this method may lead tolarge diamond-shaped cells near the center line. These largediamond-shaped structures 6052 may be further subdivided to furthersupport the stabilizing structure by including smaller diamond shapes6054 within larger shapes. In some embodiments, these smaller shapes6054 within a larger shape 6052 may comprise any shape disclosed hereinthis section or elsewhere in the specification. The larger cells may befurther subdivided by two smaller shapes, three smaller shapes, foursmaller shapes, or more than four smaller shapes. It will be understoodby one of skill in the art that the mirror line need not be confined toa line perpendicular to the longitudinal orientation of the wound.Instead, the mirror line may be located along the longitudinal axis ofthe wound or at an angle to the longitudinal axis of the wound. In someembodiments, the stabilizing structure may contain multiple mirrorlines, thereby having multiple subsections that are symmetrical ordifferent.

As illustrated in FIG. 3C, for a four-sided cell to collapse, it mustfollow a simple formula: a+b=c+d, where a, b, c, and d are the lengthsof individual sides of a single cell within the stabilizing structuresuch as the cell 6060 of FIG. 3C. When members c and b collapsetogether, then d and a collapse together. Such a formula may be thebasis for developing a pattern for a stabilizing structure thatmaximizes collapsibility.

FIG. 3D illustrates an expansion of the concept described in FIG. 3C. Byusing the base formula a+b=c+d, the elongate strips were progressivelylengthened (a4>a3>a2>a1) towards the horizontal mirror line 6050,thereby achieving a curve in the stabilizing structure while preventingany of the intervening members 6062 from becoming perpendicular to theelongate strips 6064 (i.e. having an internal angle of 90 degrees). Asillustrated in FIG. 3D, a value for b1 may be chosen, at which point anarbitrary offset value x may also be chosen to ease the construction ofthe various cell geometries. Using the progressive values for a1 througha4, illustrated visually in FIG. 3D 6066, values for b1-b4 may becalculated 6068. Using calculated values derived from equations 6068 forthe various walls of the individual cells allows for the design of astabilizing structure that collapses completely, such as those depictedin FIGS. 3A-B.

In some embodiments, a method for generating a stabilizing structuredesign may include steps to speed up the initial geometry construction.For example if all members from left to right in a specific row, asvisualized by intervening members 6036 in FIG. 3E, a pattern thenemerges where alternating vertical members are also the same length.Walls of the same length are indicated by their respective labels 6070,6072, 6074, and 6076. Once the initial design is generated thenindividual cells may be modified by lengthening, shortening, removing orinserted according to the formulas of FIG. 3D to achieve the desiredshape of the overall stabilizing structure.

The Anchoring Layers of FIGS. 4-6B

FIG. 4 illustrates an embodiment of an anchoring layer 4800 that maysurround the stabilizing structures as described in this section orelsewhere in this specification. The ring 4800 can comprise a layer oftissue anchors 4802 configured to grip the surrounding edges of a wound.For example, the tissue anchors can be hooks, barbs, prongs, or otherstructures that serve to attach to the tissue of a wound. In certainembodiments, the tissue anchors comprise hook and loop fasteners such asthose used in Velcro technologies. In certain embodiments, the ring 4800can be comprised of foam, such as those described previously or the ringcan be comprised of a combination of a foam layer and a tissue anchorlayer 4802. A lip 4804 may extend inward from the ring 4800 and serve tooverlap the top and/or the bottom of a stabilizing structure asdescribed in this section or elsewhere in this specification, therebysecuring the ring 4800 around the stabilizing structure.

FIGS. 5A-D are photographs of a wound closure device 5000 according toanother embodiment. The wound closure device 5000 comprises astabilizing structure 5002 which may be similar to the structuresdescribed in FIGS. 2A-3E, or may comprise any of the stabilizingstructures described elsewhere in this specification. The stabilizingstructure 5002 may optionally be surrounded by a porous layer 5004 suchas a layer of foam, and the porous layer may be surrounded by ananchoring layer 5006 comprising tissue anchors such as those anchorsproduced by Velcro industries, various barbs and/or various hooks. Incertain embodiments, the porous layer may be in the form of a ribbon.The stabilizing structure 5002, porous layer 5004 and anchoring layer5006 may be provided as separate components to be attached by thepractitioner in use, or they may be pre-attached to each other.

Similar to the embodiments illustrated in FIGS. 2A-3E, the stabilizingstructure 5002 can collapse in any manner described elsewhere in thisspecification, for example, horizontally. When the wound closure device5000 is implanted, the surrounding tissues can be pressed against thetissue anchors to embed them within the tissue and anchor the device. Insome embodiments, the wound closure device 5000 may be placed in a woundand sealed with a drape. Although the embodiments further described inthis section comprise an anchor layer that surrounds a porous layer,other embodiments may omit the porous layer, such that the anchoringlayer directly surrounds or is attached to the stabilizing structure.

In some embodiments, the anchoring layer 5006 comprises an elongatestrip of material comprising a plurality of tissue anchors extendingfrom a base layer 5007, wherein the tissue anchors can have differentshapes and sizes as described elsewhere in the specification. The tissueanchors may extend from a first planar side of the elongate strip, andthe second planar side of the elongate strip may comprise an adhesivecovered by an adhesive backing layer. The structure of the anchors canhave various forms depending on the tissue they are intended to bind.Longer anchors can be used for loosely bound tissues such as fat orconnective tissue, while shorter anchors can be used for denser tissuessuch as muscle. In other embodiments, depending upon the shape of theanchor, shorter anchors may be more desirable for softer, fatty tissue,while longer anchors are utilized for denser tissues. Anchors with morerigid stems can be utilized to penetrate denser tissues. In someembodiments, anchors can have bilateral prongs that tend to collapseupon insertion in tissue and yet expand when pulled in an oppositedirection such that a certain pulling force can be applied to tissue.The characteristics of the anchors or attachment mechanisms, and theirresulting force profiles, can vary by a number of parameters, such asthe length of the anchor, the shape of the attachment mechanisms, thestructure of grasping features, the material(s) used for the attachmentmechanisms, the relative flexibility/rigidity of the attachmentmechanisms, and the spacing/density of the attachment mechanisms.

The anchors may have various lengths for optimal penetration of thesurrounding tissue. For example, the length of the anchors may be atmost about 0.01 mm, at most about 0.1 mm, at most about 0.2 mm, at mostabout 0.5 mm, at most about 1 mm, at most about 2 mm, at most about 3mm, at most about 5 mm, at most about 10 mm, at most about 20 mm, atmost about 30 mm, at most about 40 mm, at most about 50 mm, at mostabout 75 mm, at most about 100 mm, or more than 100 mm.

FIG. 5B is a photograph of a closer view of the anchoring layer 5006 ofthe wound closure device 5002 depicted in FIG. 5A. The anchoring layermay consist of a first band of longer anchors 5008 configured tosurround the porous layer 5004 and stabilizing structure 5002, and asecond band of shorter anchors 5010 configured to surround the porouslayer 5004 and stabilizing structure 5002. As illustrated, the firstband 5008 may be disposed above the second band 5010. In someembodiments, there may be additional alternating series of bandsvertically relative to each other. In further embodiments, the differentbands may have different anchor lengths and shapes, as disclosed hereinthis section and elsewhere in the specification. For example, instead of2 types of bands with 2 types of anchors, there may be 3 types of bandwith 3 types of anchors or 4 types of bands with 4 types of anchors andso on. Preferably, the anchors are selected for the appropriate tissuetypes. For example, returning to FIG. 5B, the first band 5008 maycomprise longer anchors, desirable for penetration into the denserfascia, and thus may be positioned towards the bottom of the device.Similarly, the second band 5010 comprises shorter double hooks,desirable for penetration into denser tissue. Other suitable tissueanchors, as described elsewhere in this specification, include the hookand loop configuration of Velcro, barbs, hooks, spikes, pegs,arrowheads, or any suitable shape. Further examples of surfaces includetextured surfaces, such as roughened sandpaper-like surfaces, ornano-textured surfaces that may facilitate tissue adhesion.

In some embodiments, the use of surface anchors can be used incombination with a surgical adhesive, providing a much stronger bondbetween tissue layers than the adhesive alone, and providing temporaryadhesion while the adhesive sets. In some embodiments, the surgicaladhesive can be added to the anchors themselves. In certain embodiments,the surgical adhesive may simply be applied between the anchors to coatat least a portion of the anchoring layer. In further embodiments, theanchors may be replaced with a surgical adhesive, and the surgicaladhesive may act to anchor the device to the surrounding wound.

In certain embodiments, the anchors may be constructed from a variety ofmaterials, including any materials disclosed elsewhere in thespecification, such as: synthetic or natural polymers, metals, ceramics,or other suitable materials. The anchors may be constructed frombiodegradable materials such as biodegradable synthetic or naturalpolymers. Non-limiting examples of biodegradable synthetic polymersinclude: polyesters such as polylactic acid or polyglycolic acid,polyanhydrides, and linear polymers with biodegradable linkages.Further, the anchors may be constructed of biodegradable biologicalmaterials, such as autografts, allografts, and/or xenografts.

FIG. 5C is a photograph of an embodiment of a wound closure device 5000,similar to the wound closure devices of FIGS. 5A-B. However, in thisorientation the first band 5008 of anchors is towards the bottom of thedevice, while the second band of anchors 5010 is towards the top. Asdescribed above, the bands of anchors may be arrayed in any desiredmanner. FIG. 5D is a top view of an embodiment of a wound closure device5000, similar to the wound closure devices of FIGS. 5A-C.

Considering the anchoring layer of FIGS. 5A-D, the shape of theanchoring layer is not limited to the ring shape of FIG. 4. In someembodiments, the anchoring layer is wrapped around the entirety of thestabilizing device, i.e. the top, bottom, and sides. In otherembodiments, the anchoring layer is only around a portion of theperimeter of the stabilizing structure. In certain embodiments, theanchoring layer is only attached to discrete portions of the stabilizingstructure as needed. In some embodiments, the anchoring layer covers atmost about 5%, at most about 10%, at most about 20%, at most about 30%,at most about 50%, at most about 75%, and at most about 100% of theoutside of the stabilizing structure. In embodiments, the anchoringlayers may be incorporated on any face of the stabilizing clips of FIGS.23A-31H, discussed in greater detail below.

In some embodiments, the bands of different tissue anchors can beorganized in a vertical direction, while in other embodiments, they maybe organized in a horizontal direction. They may also be organized ineither the horizontal and vertical directions when considered in the xyplane, i.e. facing downward into the wound.

In certain embodiments, the different types of anchors may beinterspersed with one another, rather than organized into discrete bandsof specific types of anchors. For example, the longer anchors may besurrounded by smaller anchors and vice-versa. In some embodiments, theanchors may be organized randomly across the anchoring layer or in othersuitable patterns.

In particular embodiments, the anchoring layer may be disposed on theinner faces of the stabilizing structure. For example, the anchoringlayer may cover at most about 5%, at most about 10%, at most about 20%,at most about 30%, at most about 50%, at most about 75%, and at mostabout 100% of the interior surfaces of the stabilizing structure.

In further embodiments, the entire anchoring layer may be comprised ofonly one type of anchor, for example the entirety of the anchoring layermay be comprised of the longer hooks 5008 or the shorter hooks 5010 asdepicted in FIG. 5B. Some embodiments may call for the anchors to becolor coded. For example, the anchors on the bottom may be made to beone color while the anchors on the top may be another so as to identifythe proper orientation of the stabilizing structure in the wound.

FIGS. 6A-B are pictures of embodiments of an anchoring layer 12000 withanchors 12008, similar to the anchors depicted in FIGS. 5A-D. Examplesof such anchors may be available from Alfatex. In one embodiment, ananchoring layer may be provided comprising a 3D fabric material orportion thereof. For example, a 3D fabric may comprise a woven fabriclayer provided along a first plane and a plurality of monofilamentsextending perpendicularly from or at an angle relative to the wovenfabric layer. The woven fabric layer may be configured to be attached todirectly or indirectly to the outside of a stabilizing structure asdescribed elsewhere in this specification and in the applicationsincorporated by reference. Monofilaments may have a mushroom-shaped heador other shapes configured to engage tissue surrounding the stabilizingstructure. The head of the monofilaments may be similar to a peenedrivet with a flatted head and extended edges that engage the surroundingtissues. If the monofilaments protrude at an angle then the materialcreates more grip in one direction of shear than another. Thisdirectionality means the anchoring layer and monofilaments can bepositioned on a stabilizing structure so that the shear acts to stop thedevice being forced up or out of the wound by the viscera but can beeasily released by pushing it down.

Wound Closure and Treatment Methods of FIGS. 7-15E

The stabilizing structures and/or wound closure devices described inthis section or elsewhere in this specification may be used inconjunction with methods or systems for the closure of a wound. In someembodiments of methods of use for closure of a wound, one or more of thestabilizing structures or wound closure devices of any of theembodiments described in this section or elsewhere in this specificationis placed into a wound. In some embodiments, an organ protection layermay be provided in the wound before placement of the stabilizingstructure. In certain embodiments, foam or other porous material may beplaced in the wound along with the stabilizing structure or woundclosure device, either below, above, or surrounding the stabilizingstructure or wound closure device. Foam or other porous material mayalso surround the perimeter of the stabilizing structure or woundclosure device. The stabilizing structure or wound closure device may beconfigured to collapse in any manner as described in this section orelsewhere in this specification, for example by having a particular sizeand shape, or by comprising a certain volume of foam or other porousmaterial within the cells of the structure. The stabilizing structure orwound closure device may further be altered in any manner described inthis section or elsewhere in this specification so as to betteraccommodate the shape of the wound. After placement in the wound, thestabilizing structure or wound closure device can be sealed by afluid-tight drape. The fluid-tight drape can comprise a port configuredfor the application of negative pressure. A source of negative pressuremay then be connected to the port and negative pressure may be appliedto the wound. The stabilizing structure or wound closure device may bereplaced over time by stabilizing structures or wound closure devices ofvarious shapes and sizes as desired to best promote wound healing.

FIGS. 7-15E are photographs and illustrations depicting embodiments ofmethods for the treatment of a wound that utilize a wound closure devicecomprising a stabilizing structure as described herein this section andelsewhere in the specification. To better illustrate non-limitingembodiments of the methods, numbers have been added to the steps of FIG.13 to allow the reader to more easily follow these steps of the method.However, the steps can be performed in any order, and any numberingsystem is for clarity only. Further, in some embodiments, differentsteps of these methods may be excluded. In other embodiments, additionalsteps may be added to the methods based on methods described herein thissection and elsewhere in the specification. The porous layers andstructures described in this section may be of any material or structuredescribed elsewhere in the specification, such as foam.

FIG. 7 depicts an embodiment of an open wound 5100 prior to treatmentwith a wound closure device as will be described in much greater detailbelow. The open wound of FIG. 6 is similar to the wounds describedelsewhere in the specification, particularly as relate to FIG. 1. Insome instances, as described elsewhere in the specification, such awound may be produced via a surgical incision or other means.

FIG. 8 depicts an embodiment of an initial step in a method for thetreatment of an open wound 5100 with a wound closure device. Beforetreatment, the wound may be cleaned with a pad 5180 and the skin 5190prepared for application of a wound closure device, such as thosedescribed in relation to FIGS. 2A-3E.

FIG. 9 depicts an embodiment of an early step in a method for thetreatment of an open wound 5100. In some embodiments, a tissueprotection layer 5170 may be placed over the wound to protect theunderlying tissues from the rigors of negative pressure wound therapy orother potential harms. Accordingly, certain embodiments provide for atissue protection layer 5170 which may be cut to size to be placed overthe wound site 5100. The tissue protection layer 5170 can be a materialwhich will not adhere to the wound site or to the exposed viscera inclose proximity. Such a tissue protection layer may be constructed fromany suitable material such as a biocompatible polymer. For example,organ protection layers manufactured by Smith & Nephew and sold underthe brand RENASYS® may act as tissue protection layers and be placedover the abdominal cavity and/or wound bed 5100 and tucked over theperitoneal gutter. In further examples, materials such as thefluoropolymer polytetrafluoroethylene (PTFE) may be applicable as thesematerials are generally non-adherent and used in surgical grafts. In oneembodiment, the tissue protection layer is permeable. For example, thetissue protection layer 5170 can be provided with openings, such asholes, slits, or channels, to allow the removal of fluids from the woundsite 5100 or the transmittal of negative pressure to the wound site5100. In further embodiments, the tissue protection layer may be usedover non-abdominal wounds on other areas of the body, such as the leg,arm, shoulder, or back. In certain embodiments, the tissue protectionlayer may comprise a sensor configured to measure pressures in andaround the wound. For example, the sensor may be used to measure thelevel of negative pressure applied to the wound or to measure thepressure on the underlying organs beneath the abdominal wound.

FIGS. 10A-C illustrate embodiments of possible initial steps in a methodfor the treatment of an open wound. However, as described above, thesteps need not be performed in this order and may be performed in anyorder. In FIG. 10A, two pieces of a porous material such as foam, abottom piece 5102 and a top piece 5116 are selected so as to approximatethe size of the wound 5100. In some embodiments, the top piece and thebottom piece are of identical thickness. However, in certainembodiments, and vice-versa, top piece 5116 may be at least twice asthick, at least four times as thick, at least 10 times as thick or morethan ten times as thick as bottom piece 5102. FIG. 10B illustrates anembodiment of additional steps in a method for the treatment of an openwound. Bottom piece 5102 may be shaped via cutting or other suitablemeans to the shape of the wound and subsequently placed into the wound5100, as shown in FIG. 10C and depicted further below in FIG. 11A.

FIGS. 11A-B are photographs of a foam layer 5102 (for example, a 15 mmlayer of foam), after shaping, placed into a wound bed 5100. In FIGS.12A-C, a stabilizing structure 5104 similar to the stabilizingstructures disclosed in FIGS. 2A-3E or any other stabilizing structuredescribed elsewhere in the specification, is in the shape of the wound.The stabilizing structure may be shaped into the shape of the wound viacutting or other suitable means or the stabilizing structure mayinitially be of a size that is readily accommodated by the wound. Asdisplayed in FIG. 12B, the stabilizing structure 5104 may be placed intothe wound. To assist with the insertion of the device into the woundbed, the device can be deformed slightly inwardly or horizontally tofacilitate entrance into the wound site. In some embodiments, the devicemay be squeezed slightly during insertion and then release upon contactwith the walls of the wound. In certain embodiments, the wound closuredevice 5104 may be placed such that the longitudinal sides of the matrixalign with the longitudinal axis of the wound 5100. Continuing with FIG.12B, another foam layer 5116 (for example, a 10 mm layer of foam) isplaced on top of the wound closure device 5104.

FIG. 12C is a photograph of application of a port 5122 to thestabilizing structure and foam of FIGS. 12A-B. A bridging portion offoam 5118 may be placed in intimate contact with the foam layer 5116 atthe edge of the wound. The bridging portion of foam 5118 may extend overintact skin, with a piece of drape 5120 placed between it and the intactskin. Further, a suction port 5122 may be connected to the bridgingportion 5118 with a section of drape 5120 between. In alternativeembodiments, the bridging portion 5118 and suction port 5122 may beplaced on the wound during a different step depicted in FIGS. 11A-12B.

In FIG. 13, as shown by steps 1-4, the device may be covered by one ormore drapes 5120. A hole may be made in the drape covering the bridgingportion of foam, and a suction port 5122 may be placed over the hole. Aprotective layer 5124 on the top surface of the one or more drapes maybe removed after the drapes 5120 are applied. Once the drapes 5120 areapplied and the port is in place, negative pressure may be applied tothe wound through the drape from a vacuum source. The negative pressurecan cause the stabilizing structure to collapse horizontally asdescribed elsewhere in this specification. The tissue anchors adhered tothe stabilizing structure through the porous layer engage tissue of thewound and may facilitate closure of the wound.

FIGS. 14A-14C provide further illustrations of an upper foam layer 5116being placed in a wound, followed by placing a bridging portion 5118 andplacing one or more drapes or wound covers 5120. FIGS. 14D-14Gillustrate an embodiment of several steps in a method for the treatmentand closure of a wound. As illustrated in FIG. 14D, a suction port 5122is separated from a release liner 5126 and later applied to a wound asdepicted in FIGS. 11A-13. FIG. 14E illustrates a canister 5128 beinginserted into a negative pressure wound therapy device 5130 inpreparation for the collection of wound exudate. FIG. 14F illustratesthe snap connection between the tubing connected to the suction port andthe tubing connected to the negative pressure wound therapy device 5130.Once the connection has been made, negative pressure wound treatment maybegin as depicted in FIG. 14G.

FIGS. 15A-E are photographs and a drawing of a prior art or alternativemethod for closing a wound, with some similarities to the methods ofFIGS. 7-14G. Here, foam is placed under the muscle and fascia, followedby foam extending vertically out of the wound and folded over. Such amethod may provide enhanced closure of the dermis but possibly not atthe fascia level. In alternative embodiments, such a configuration maybe combined with a stabilizing structure such as those disclosed hereinthis section and elsewhere in the specification, by providing a foldedover foam layer 5116 that bulges out of the wound. FIG. 15E is across-sectional drawing of the prior art or alternative method.

Further details regarding the wound closure devices, stabilizingstructures, related apparatuses and methods of use that may be combinedwith or incorporated into any of the embodiments described herein arefound elsewhere throughout this specification and in InternationalApplication No. PCT/US2013/050698, filed Jul. 16, 2013, published as WO2014/014922 A1, the entirety of which is hereby incorporated byreference.

The Stabilizing Structures of FIGS. 16-19D

FIG. 16 is a drawing of an embodiment of a stabilizing structure 6100,similar to the stabilizing structures of FIGS. 2A-3E. Stabilizingstructure 6100 may be constructed via any means described herein thissection or elsewhere in the specification, such as via 3D printing andvia the calculation method described in FIGS. 3A-3E. Further,stabilizing structure 6100 may be constructed from any materialdescribed herein this section or elsewhere in this specification such asthe materials described in relation to FIGS. 2A-3E. Similar to thestabilizing structures of FIGS. 2A-3E, stabilizing structure 6100comprises a plurality of elongate strips 6106 arranged in parallel orsemi-parallel, whose longitudinal length can be aligned with thelongitudinal axis of a wound. In embodiments, the elongate strips 6106may also be arranged in a non-parallel fashion. The various cells withinthis stabilizing structure 6100 may have a variety of shapes and sizes.As was described in greater detail above, the length and shape of theelongate strips 6106, intervening members 6110, and cells 6104 may bedesigned so as to facilitate greater closure of the stabilizingstructure.

In embodiments, the stabilizing structure of FIG. 16 differs from thestabilizing structures of FIGS. 2A-3E, due to the inclusion of anextended section 6120. Extended section 6120 comprises one or moreadditional cells that extend outward along the longitudinal axis of thestabilizing structure 6100. Extended section 6120 may allow thestabilizing structure to better fit within a long incisional wound.Further, the addition of extended section 6120 may serve to preventpinching of the surrounding tissue during collapse of the stabilizingstructure 6100. Extended section may comprise about 6 additional cell,12 additional cells, 16 additional cells, 20 additional cells, 30additional cells, or more than 30 additional cells.

As depicted in FIG. 16, extended section 6120 may include additionalrows having progressively fewer cells across its width. For example,extended section 6120 may comprise a row of four cells, then a row oftwo cells, followed by another row of two cells. In some embodiments, arow of six cells precedes the row of four cells. The extended section6120 extends beyond the outer edge of a virtual ellipse formed by themajority of the perimeter of the stabilizing structure along thelongitudinal axis of the stabilizing structure. In certain embodiments,the extended section may extend from both ends of the stabilizingstructure along the longitudinal axis. The extended section 6120 in someembodiments provides a stepped outer perimeter to the outer wall of thestabilizing structure at the longitudinal edges of the stabilizingstructure, in contrast to the continuous outer perimeter along the sidesof the stabilizing structure 6122.

Absent the extended section 6120, the stabilizing structure comprisesnon-stepped side walls along substantially the entire length of theoval. However, with the extended section, the additional rows mayprovide a stepped outer perimeter 6124 based on the additional rows, incontrast to the flattened oval end of the stabilizing structure 6126.Further embodiments of the extended section will be described in moredetail below in relation to FIGS. 17A-17E.

FIGS. 17A-17E are drawings and pictures of embodiments of stabilizingstructure 6200, similar to the stabilizing structures of FIGS. 2A-3E andFIG. 16. Much like the stabilizing structures disclosed elsewhere in thespecification, stabilizing structure 6200 comprises elongate strips6206, cells 6204, and intervening members 6210. Stabilizing structure6200 further comprises extended sections 6220 at both ends of thelongitudinal axis of the stabilizing structure. As described above inrelation to FIG. 16, extended sections 6220 may allow the stabilizingstructure to better fit within the contours of a wound. Further,extended sections 6220 may prevent pinching of the surrounding tissueafter collapse of the stabilizing structure. As described above,extended section may comprise multiple cells.

The stabilizing structures of FIGS. 17A-17E, and any of stabilizingstructure disclosed herein this section or elsewhere in thespecification may be produced in a variety of sizes. The possible sizeand shape of an actual wound may vary dramatically in size and shape,thus suitable stabilizing structures may also be prepared in a varietyof sizes. For example, the length of an un-collapsed stabilizingstructure may be approximately at least 25 mm, 50 mm, 75 mm, 100 mm, 125mm, 150 mm, 175 mm, 200 mm, 250 mm, 300 mm, 350 mm, 400 mm, 450 mm, 500mm, 750 mm, or greater than 750 mm. In certain embodiments, the width ofan un-collapsed stabilizing structure may be at least 10 mm, 15 mm, 25mm, 35 mm, 50 mm, 75 mm, 100 mm, 125 mm, 150 mm, 175 mm, 200 mm, 250 mm,300 mm, 350 mm, 400 mm, 450 mm, 500 mm or greater than 500 mm.

As depicted in FIG. 17E, in some embodiments the un-collapsedstabilizing structure may have a length of approximately 242 mm.However, the stabilizing structure may be of any size disclosed hereinthis section or elsewhere in the specification. The cells 6204 of thestabilizing structure may be of a variety of sizes, for example thewidth of a cell 6204 may be approximately at least 5 mm, 10 mm, 15 mm,20 mm, 25 mm, 30 mm, 50 mm, or more than 50 mm. For example, the lengthof a cell may be approximately at least 5 mm, 10 mm, 15 mm, 20 mm, 25mm, 30 mm, 50 mm, or more than 50 mm.

In some embodiments, extended sections 6220 may comprise a first row offour cells, followed by a row of two cells, followed by another row oftwo cells. The row of four cells may be preceded by a row of six cells.However, in further embodiments, the extended section may comprisevarious numbers of cells per row and different numbers of rows. Forexample, extended section may comprise 1 row, 2 rows, 3 rows, 4 rows, 5rows, 6 rows, or more than 6 rows. In embodiments, the rows may comprise1 cell, 2 cells, 3 cells, 4 cells, 5 cells, 6 cells, 8 cells, 10 cells,16 cells, or more than 16 cells.

Returning to FIG. 17A, in certain embodiments, the extended section maycomprise a series of cells 6104 comprising walls that are semi-parallel6230 to the longitudinal axis of the stabilizing structure. These cellwalls contrast with cell walls elsewhere in the stabilizing structurewhich comprise walls that run at an angle 6240 to the longitudinal axisof the stabilizing structure 6200.

In embodiments of the stabilizing structure comprising extended sections6220, elongate members 6206 closest to the central longitudinal axis ofthe stabilizing structure extend further along the longitudinal axisthan embodiments of the stabilizing structure that do not comprise anextended section. For example, the innermost elongate strips are thelongest strips, while the next innermost strips are the second longestand so on. The presence of the extended sections causes the stabilizingstructure when viewed from above to appear to be more eye-shaped ratherthan more oval-shaped.

As depicted in FIG. 17A-C, in embodiments, the stabilizing structure6200 may be oculiform. An oculiform shape may appear to be shaped like ahuman eye, with curved upper and lower edges converging to points ateither longitudinal pole in the corners of the eye. Here, the outerwalls curve inward 6250 to converge at the extended sections 6220. Thisshape is in contrast to a more diamond shape (not shown) where the outerwalls would converge in a straight line to extended section 6220.However, in some embodiments, the stabilizing structure may be in theform of a diamond, rather than an oculiform.

Stabilizing structure 6200 further comprises tabs 6212 extended outwardfrom the outer wall of the stabilizing structure 6200. Such tabs mayextend outward from the top or the bottom of the stabilizing structureor both. The tabs may extend out from all outer cells of the stabilizingstructure as depicted by FIG. 17C or the tabs may alternate as depictedin FIG. 17A. FIG. 17D is a photograph of a close up view of a tab 6212.The tabs may be constructed from any material described herein thissection or elsewhere in the specification, such as those materials usedfor construction of the stabilizing structures. In certain embodiments,the tabs may be 3D printed as part of the stabilizing structure.

The tabs 6212 may further comprise an anchoring layer, such as thosedescribed above in relation to FIGS. 4-6B. This anchoring layer may beused to adhere the tabs to a layer of foam. In embodiments, the tabs maybe coated in a suitable adhesive, allowing the tabs to be adhered to alayer of foam. The attachment of foam to the upper and lower layers ofthe stabilizing structure will be described in greater detail below inrelation to FIG. 20A-22E. The tabs may further serve to extend outwardabove or below tissues surrounding the stabilizing structure or aroundother structures such as foam, wrapped around the perimeter of thestabilizing structure.

The stabilizing structures of FIGS. 17A-17E may be provided in a varietyof sizes such as those described above in relation to FIGS. 2A-3E. Asdescribed above, it may be advantageous in a clinical setting tominimize adjustments to the size of the stabilizing structure, thereforea kit may be provided that includes stabilizing structures of varioussizes that may be fit to a wound of the appropriate size. For example,the kit may comprise only two sizes of matrices, a large size and asmall size. The larger size stabilizing structure may be at least about1.25×, 1.5×, 1.75×, 2×, 2.5×, 3×, 4×, 5×, 6× or greater than 6 times thesize of the smaller stabilizing structure.

FIGS. 18A-D are photographs of multiple views of the stabilizingstructure 6200 of FIG. 17B, in a collapsed state. During collapse, thelength and height of the stabilizing structure remain approximately thesame while the width decreases dramatically. As described above, thestabilizing structure may collapse in such a manner when subjected tonegative pressure, thereby facilitating closure of the wound. As shownin FIG. 18A, in some embodiments, the extended sections 6220 may avoidcollapse, however as shown in FIGS. 18C-D, in embodiments the extendedsection will collapse along with the remainder of the stabilizingstructure.

FIGS. 19A-B depict further embodiments of stabilizing structures 6300,similar to the stabilizing structures disclosed herein this section orelsewhere in the specification. The pattern of the stabilizingstructures of FIGS. 19A-B comprises a series of cells symmetricallyoriented around a mirror line 6302 along the minor axis of thestabilizing structure. In embodiments, the stabilizing structure of FIG.19A has an un-collapsed width of 300 mm and a length of approximately510 mm, while the stabilizing structure of FIG. 19B may have anun-collapsed width of 242 mm and length of 343 mm. The largest cells ofthe stabilizing structure of FIG. 19B may have a width of 30 mm.However, it will be understood by one of skill in the art that thestabilizing structures of FIGS. 19A-B may comprise any size and shapedisclosed herein this section or elsewhere in the specification.

The Stabilizing Structures and Foam Layers of FIGS. 20A-22E

FIGS. 20A-22E are drawings and photographs of foam layers in combinationwith stabilizing structures such as those described above in relation toFIGS. 2A-3E and 16-19B. The foam layers described below may include anytype of foam described herein this section or elsewhere in thespecification. Possible foams may include open-celled and/or reticulatedfoams made from a polymer. Suitable foams include foams composed of, forexample, polyurethane, silicone, hydrophobic materials, hydrophilicmaterials, open-celled materials, close-celled materials, mixed open andclose-celled materials, reticulated materials, polyester, silicone,and/or polyvinyl alcohol. In embodiments, the foam layers describedherein may include materials that change their properties over time. Forexample, a particular foam may be rigid initially but become moreflexible when wet and/or lose rigidity over time due to degradation ofthe material.

The foam layers described in this section or elsewhere in thespecification may have a variety of suitable thicknesses. For example, afoam layer may have a thickness of at least about 1 mm, 3 mm, 5 mm, 10mm, 15 mm, 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, or more than50 mm thick. Single layers of foam may be laid atop one another tocreate a greater total thickness of foam, for example, a 15 mm thicklayer of foam may be laid atop a 10 mm layer of foam to create a 25 mmtotal thickness of foam.

In certain embodiments, any of the foam layers described herein thissection or elsewhere in the specification, may be pre-attached to anorgan protection layer such as described above. For example, the lowestlayer of foam, closest to the underlying organs, may be attached to anorgan protection layer before placement within the wound, thereby savingthe clinician the step of first placing an organ protection layer withinthe wound. In certain embodiments, the organ protection layer may bepre-attached to the underside of a stabilizing structure such as thosedescribed herein this section or elsewhere in the specification. Inembodiments, the organ protection layer may be attached to the top ofthe bottom-most foam layer placed in the wound, thereby positioning theorgan protection layer between the stabilizing structure and thebottom-most layer of foam. The organ protection layer may completelyencase the bottommost layer of foam or stabilizing structure. Thepresence of a bottom layer of foam and/or organ protection layer mayserve to protect the underlying bowel from damage due to directinteraction with the stabilizing structure.

FIGS. 20A-D are drawings and photographs of embodiments of a woundclosure device 6350 comprising a stabilizing structure 6302 (similar tothe stabilizing structures described above in relation to FIGS. 2A-3Eand 16A-19D), a top porous foam layer 6352, and a bottom porous foamlayer 6354. As will be described in greater detail below, top and bottomporous layers 6352 and 6354 may be shaped in any desired manner toconform to the shape of stabilizing structure 6302. In embodiments, thetop and bottom layers of foam may be attached to the stabilizingstructure 6302 before placement in the wound. Pre-attachment of the foamlayers advantageously reduces the number of steps that need to becompleted by the clinician

As described elsewhere in the specification, stabilizing structure 6302may comprise tabs 6304. These tabs advantageously provide a largersurface area for attachment of the foam layers to the stabilizingstructure. Without the tabs, adhesive would necessarily need to beapplied to the narrow upper edges of the stabilizing structure,potentially creating a weak or non-existent attachment. As describedabove, the tabs may be located on the top and bottom edges of thestabilizing structure. In embodiments, rather than adhesive, the tabsmay be covered in anchors, such as those described above in relation toFIGS. 4-6B. The anchors act much like the adhesive, allowing the foamlayers to be attached to the stabilizing structure prior to placement inthe wound. The stabilizing structure may be pre-attached to the bottomlayer of foam, top layer, or both. In certain embodiments, the adhesivemay be applied to the central longitudinal elongate member of thestabilizing structure rather than to the tabs or other location. Byapplying adhesive only to the central elongate member, the stabilizingstructure may collapse without resistance from the foam.

FIGS. 20A-D show embodiments of wound closure devices where the bottomfoam is larger than the top foam, either by width, length, or both.Here, the foam extends outward from the stabilizing structure to createa lip, thereby allowing the lip of foam to extend above or below thesurrounding tissue layers such as the fascia. The lip may serve tomaintain the stabilizing structure in place by providing a downwardforce to resist the upward force applied by the expanding underlyingviscera. In certain embodiments, the lip may need to be folded duringplacement within the wound bed so as to allow the closure device to beproperly positioned. Thereafter the lip may unfold and extend into thesurrounding tissues to aid in securing the device and applying negativepressure to the surrounding tissues.

The top layer may be sized to the top of the stabilizing structure,thereby facilitating closure of the wound to the size of the collapsedstabilizing structure. The lip extending outward from the matrix may berounded so as to provide a better fit within the wound. In contrast, inthe embodiment of FIG. 20E, the bottom layer may be smaller than the toplayer. The top layer may advantageously prevent drawing of the drapedown into the stabilizing structure or between the stabilizing structureand the edges of the wound.

In certain embodiments, the foam layers may be of any thicknessdisclosed herein this section or elsewhere in the specification. Thebottom layer of foam 6354 may be approximately 15 mm thick orapproximately 10 mm thick. For example, the bottom foam 6354 of FIG. 20Dis thicker than the bottom foam of FIG. 20C.

FIGS. 20E-20F depict an embodiment of a wound closure device involving atotal of 3 layers of foam. Here, wound closure device 6350 comprisesstabilizing structure 6302, top layer of foam 6352, bottom layer of foam6354, and middle layer of foam 6356. The stabilizing structure may bepre-attached to the middle layer of foam, top layer of foam, or both.Further, the bottom layer of foam may be pre-attached to the middlelayer of foam, or may be placed into the wound separately. In someembodiments, the top layer is 15 or 10 mm thick, the middle layer is 15mm thick, and the bottom layer is 10 mm thick. Foam layers may beattached by any suitable means, such as via adhesive or anchors. Asdepicted in FIG. 20E, the bottommost layer of foam may comprise a lipthat extends outward from the wound closure device into the surroundingtissue. As described above, such a lip may secure the device in place.The bottom layer of foam may be wider and/or longer than the middleand/or top layers of foam. In certain embodiments, in addition to thefoam on the top and bottom of the stabilizing structure, foam may beattached to the entire outer perimeter of the stabilizing structure.Foam may be attached to the perimeter of the stabilizing structure viaany suitable means, such as by adhesive or anchoring layer. Once foamhas been applied to the perimeter of the stabilizing structure, thestabilizing structure will no longer be visible if there are also topand bottom layers of foam.

In embodiments of the foam layers of FIGS. 20A-20F, the layers of foammay comprise any type of suitable foam material described herein thissection or elsewhere in the specification. For example, the foam maycomprise “black foam” such as polyurethane and/or “white foam”comprising polyvinyl alcohol (PVA). In embodiments involving PVA foam,thinner foam layers may be needed as compared to other types of foam,because PVA foam is often more resilient and dense than other types offoam. Further, once PVA foam becomes wet it may also aid with lateralslip. In some embodiments, the foam layers may be combined with otherfillers such as gauze, or other mesh/net products such as those on Fryand Kossel.

FIG. 21 is a photograph of an embodiment of a foam layer 4600 that maybe used in combination with any of the stabilizing structures or woundclosure devices described in this section or elsewhere in thisspecification. The foam layer of 4600 may be used in place of any foamlayer described herein this section or elsewhere in the specification.As described in this section and elsewhere in the specification, thefoam layer 4600 may be located above or below the stabilizing structureor wound closure device. In some embodiments, the foam layer 4600 islocated both above and below the stabilizing structure or wound closuredevice. The foam layer 4600 can surround the perimeter of thestabilizing structure or wound closure device or completely surround theentirety of the stabilizing structure or wound closure device. The foamlayer 4600 can be constructed from absorbent materials, materialsconfigured to distribute fluid, or both.

The foam layer 4600 further comprises fingers 4602 that can extend fromthe foam layer into the stabilizing structure or closure device. Forexample, the fingers 4602 may extend into and around the gaps or cellsdepicted in the stabilizing structures described herein this section orelsewhere in the specification. The fingers 4602 may also extend aroundthe outside of the perimeter of the stabilizing structure. In someembodiments, the fingers 4602 from one foam layer 4600 may extendthrough the interior or around the outside of the stabilizing structureto meet the fingers 4602 from a second foam layer 4600. Thus, one foamlayer will be facing finger-side up, while a second foam layer may befacing finger-side down.

In some embodiments, the foam layer 4600 can have perforations orpre-cuts to allow portions of the foam layer 4600 to be easily torn awayto shape the foam for a particular wound. In some embodiments, thefingers 4602 can extend at least about 1 mm from the surface of the foamlayer, at least about 3 mm from the surface of the foam layer, at leastabout 5 mm from the surface of the foam layer, at least about 7.5 mmfrom the surface of the foam layer, at least about 10 mm from thesurface of the foam layer, at least about 12.5 mm from the surface ofthe foam layer, at least about 25 mm from the surface of the foam layer,at least about 17.5 mm from the surface of the foam layer, at leastabout 20 mm from the surface of the foam layer, at least about 25 mmfrom the surface of the foam layer, or more than 25 mm.

In certain embodiments, the fingers 4602 can be varied so as to controlthe collapse of the stabilizing structure. For example, when a finger isextended into a particular cell of the stabilizing structure, the fingerwill prevent collapse of that particular cell. Therefore, a largernumber of foam fingers extending into the stabilizing structure willreduce collapse more than a lesser number of foam fingers. For example,the fingers may extend into at least about: 10%, 20%, 30%, 50%, 75% oreven 100% of the cells of the stabilizing structure, thereby furtherlimiting collapse of the stabilizing structure.

FIGS. 22A-22E depict foams suitable for printing instructions. Whenplacing a wound closure device such as those described herein thissection or elsewhere in the specification, it may be difficult for theclinician to determine the proper orientation of the foam layer or othercomponents of the wound closure device. Therefore, printing of symbolson the foam may make it easier for the clinician to properly orient thefoam layer. Although not shown, any of the symbols or printing disclosedherein this section or elsewhere in the specification may be applied todifferent structures of the wound closure device, such as thestabilizing structure.

FIG. 22A depicts a simple unlabeled oval of foam 6400, such a layerprovides little guidance for the proper orientation of the foam in thewound other than the general shape of the foam. FIG. 22B depicts anembodiment of a foam layer comprising horizontal stripes 6402. Thesehorizontal stripes may be aligned along the shorter axis of a wound,thereby providing for ease of placement of the foam oval 6400.Similarly, FIG. 22C depicts an oval foam layer comprising longitudinalstripes 6404 which may be aligned with the longitudinal axis of thewound. FIG. 22D is similar to FIG. 22B, in that the horizontal arrows6404 indicate alignment with the horizontal axis of the wound. Lastly,FIG. 22E combines the longitudinal stripes 6404 with the horizontalarrows 6404, but further includes “head” 6408 and “feet” 6410 symbols todirect the clinician to orient the head towards the head of the patientand the feet towards the feet of the patient.

In certain embodiments, foam layers similar to the foam layers of FIGS.22B-E may include printing on one or both sides of the foam layer toindicate to the clinician which side of the foam or wound closure deviceis the top and which side is the bottom. Printing that preciselydelineates the top, bottom, and orientation of the device may prevent aclinician from placing the wound closure device in a wound upside downor rotated in the wrong direction.

The Stabilizing Clips of FIGS. 23A-31H

FIGS. 23A-23E illustrate multiple views of stabilizing clips that may beattached to the stabilizing structures of FIGS. 2A-3E and 16-20F. Asillustrated in FIG. 23A, in some embodiments, stabilizing clip 7000 maycomprise an attachment portion 7002 that allows it to “clip” onto a wallof a stabilizing structure, such as upon an elongate member or anintervening member. Stabilizing clip 7000 may also comprise a securingportion 7004 that can extend above or below tissue layers to aid insecuring the stabilizing structure 6000 to the surrounding tissue. Thesecuring portion 7004 may extend from a lower end of the attachmentportion 7002, at the closed end of the attachment portion. For example,when a stabilizing structure, such as stabilizing structure 6000 of FIG.2A, is placed into an abdominal wound, the underlying viscera may tendto expand and push the stabilizing structure upwards and out of theabdominal wound. Such an occurrence is undesirable because, as describedabove, the stabilizing structure is suited to be placed within anabdominal wound whereby the stabilizing structure can draw the edges ofthe wound together. To alleviate the outward pressure of the expandingviscera, in some embodiments as illustrated by FIG. 23B, before placingthe stabilizing structure within the wound, the stabilizing clips 7000may be attached to the underside of the stabilizing structure 6000. Thesecuring portion 7004 of the stabilizing structure 6000 may then extendoutward from the stabilizing structure and under the surrounding tissue7010, for example the fascia 7012. This same rationale applies to thefoam lip described above in relation to FIGS. 20A-F.

In some embodiments, the clips are rigid, therefore once the securingportion 7004 is extended below the fascia 7012, the securing portion canabsorb upward force from the swelling viscera while maintaining thestabilizing structure 6000 in place within an abdominal wound. Infurther embodiments, the securing portion may be semi-rigid or soft. Insome embodiments, the clip can be made from any suitable materialincluding, for example, plastics, ABS, PU, PE, PP, PET, silicone, Nylon,or other suitable materials known in the art. Further, the clip can bemade of metals including, for example, titanium, stainless steel,Inconel, or other suitable material known in the art. Additionally, theclip can be made of composites including, for example, carbon fiber,Kevlar, reinforced plastics, or other suitable material known in theart.

The stabilizing clip may be clipped to the top or the bottom of thestabilizing structure, thereby extending the securing portion over thetop or below the surrounding tissue. In some embodiments, an anchoringlayer such as those described elsewhere in the specification,particularly in FIGS. 4-6B, may be attached to the stabilizing clip. Oneof skill in the art with recognize that such an anchoring layer may beapplied to the stabilizing clip in any suitable manner, such as aroundor under the stabilizing clip.

In some embodiments, the stabilizing clips are radiopaque, such thatthey are easily identifiable if lost within the body. To further makethe stabilizing clips easier to find, the stabilizing clips may beattached or tied together in a suitable manner. In some embodiments twostabilizing clips are attached together, three stabilizing clips, fourstabilizing clips, or more than four stabilizing clips attachedtogether.

In embodiments, the stabilizing structure may have notches such that thestabilizing clips may be help more firmly over the notch. Thestabilizing clip may further have an additional protrusion that servesto prop open the stabilizing structure such that the stabilizingstructure cannot fully close. Instead of or in tandem with a protrusion,the stabilizing clip may have a loop that acts to prop open thestabilizing structure. In some embodiments, the stabilizing clip propsopen the stabilizing structure at least: 10%, 20%, 30%, 40%, 50%, ormore than 50%.

FIG. 23C illustrates an embodiment of stabilizing clip 7006, similar tothe stabilizing clip of FIG. 23A. Stabilizing clip 7000 may comprise anattachment portion 7002 that loops over the top of a wall of astabilizing structure. In this way, the stabilizing clip 7000 will bemore difficult to dislodge from the stabilizing structure. As with theother stabilizing clip embodiments illustrated in FIG. 23A, thestabilizing clip of FIG. 23B may comprise a securing portion 7004 thatextends below a layer of tissue such as the fascia, to maintain thestabilizing structure in place. The securing portion 7004 may extendfrom a lower end of the attachment portion 7002, however, in thisinstance the lower end of the attachment portion is the open end becausethe stabilizing clip “clips” onto the stabilizing structure from thetop.

FIG. 23D depicts another embodiment of a stabilizing clip 7008, similarto the stabilizing clip embodiments of FIGS. 23A-B. Stabilizing clip7008 has securing portions 7004, 7010 on both the upper and lowerportions of the stabilizing clip. The stabilizing clip may have a firstsecuring portion 7010 extending outward from an upper end of theattachment portion and a second securing portion 7004 extending outwardfrom a lower end of the attachment portion. Therefore, once attached toa stabilizing structure, stabilizing clip 7008 may more tightly securethe stabilizing structure in place because the securing portions extendboth above and below various tissue layers such as the fascia. FIG. 23Eshows side views of stabilizing clips 7000, 7006, and 7008, while FIG.23F shows a top front view of stabilizing clips 7000, 7006, and 7008.

FIGS. 24A-E are pictures of embodiments of stabilizing structures 8000similar to the stabilizing structures of FIGS. 2A-3E and 16-20F.Stabilizing clips 8002 may be attached to the stabilizing structure tosecure the stabilizing structure within the wound. As described hereinthis section and elsewhere in the specification, the stabilizing clips8002 may extend outward from the stabilizing structure into thesurrounding tissue and hold the stabilizing structure in place withinthe abdominal wound. In some embodiments, more than one stabilizing clipwill be used. For example, a single stabilizing structure may contain 2or more of one type of stabilizing clip on one side, three or morestabilizing clips, four or more stabilizing clips, five or morestabilizing clips, six or more stabilizing clips, or more than sixstabilizing clips. Sometimes when using more than one clip, only onetype of clip is used, however, at other times more than one type of clipmay be used. In certain embodiments, there will only be one stabilizingclip per wall of the stabilizing structure; however, further embodimentsmay call for multiple stabilizing clips per wall of the stabilizingstructure. FIGS. 24F-G are illustrations of the stabilizing structureswith a larger number of stabilizing clips.

FIGS. 25A-G illustrate an embodiment of stabilizing clip 9006, similarto the stabilizing clip of FIG. 24C. Stabilizing clip 9006 may comprisean attachment portion 9002 that loops over the top of a wall of astabilizing structure. As with the other stabilizing clip embodimentsillustrated in FIG. 23C, the stabilizing clip of FIGS. 25A-G maycomprise a securing portion 9004 that extends below a layer of tissuesuch as the fascia, to maintain the stabilizing structure in place. Thesecuring portion 9004 may extend from a lower end of the attachmentportion 9002. The securing portion 9004 can include grippers 9008. Thegrippers 9008 can assist in attaching the securing portion to thesurrounding tissue. The securing portion 9004 and the grippers 9008extend below a layer of tissue such as the fascia, to maintain thestabilizing structure in place. The tissue grippers 9008 can be similarto the tissue anchors described with reference to FIGS. 4-6B. The tissuegrippers 9008 can be formed of the same material as the stabilizingclip. In some embodiments, the grippers 9008 can be formed of adifferent material than the material used for construction of thestabilizing clip. FIGS. 25A-G illustrate grippers 9008 on a top surface9010 of the securing portion 9004. In some embodiments, the grippers9008 may be provided on the bottom surface 9011, sides 9012, or frontsurface 9013 of the securing portion. Further, in some embodiments, theattachment portion of the stabilizing clips may include grippers thatcan assist in securing the stabilizing structure.

FIGS. 26A-J illustrate an embodiment of stabilizing clip 10006, similarto the stabilizing clip of FIGS. 25A-G. Stabilizing clip 10006 maycomprise an attachment portion 10002 that loops over the top of a wallof a stabilizing structure. As with the other stabilizing clipembodiments illustrated in FIGS. 25A-G, the stabilizing clip of FIGS.26A-J may comprise a securing portion 10004 that extends below a layerof tissue such as the fascia, to maintain the stabilizing structure inplace. The securing portion 10004 may extend from a lower end of theattachment portion 10002. The stabilizing clip 10006 can include a stepor recess 10010 at the intersection of the securing portion 10004 andthe attachment portion 10002 or where the securing portion 10004 extendshorizontally from the attachment portion 10002. In some embodiments, asdepicted in FIGS. 26A-J, the securing portion 10004 may include grippers10008 to assist in attaching the securing portion to the surroundingtissue. In other embodiments, the stabilizing clip 10006 with the stepor recess 10010 may be used with a securing portion 10004 withoutgrippers 10008 on the surface of the securing portion 10004. The step10010 can provide a step or recess in the stabilizing clip toaccommodate a foam and/or other material positioned below the matrix,similar to the foam layers described herein this section or elsewhere inthe specification. The step 10010 allows the stabilizing clip 10006attached to the matrix stabilizing structure 10013 to fit around a pieceof foam that is placed below the stabilizing structure 10013 which maybe slightly larger than the stabilizing structure 10013. In someembodiments, the size of the step can be changed to accommodate thevarious foam sizes.

FIGS. 26H-J are pictures of the stabilizing clip 10006 attached to astabilizing structure or matrix support 10013, similar to thestabilizing structures depicted in FIGS. 2A-3E and 16-19B. Thestabilizing structure 10013 is positioned above a foam layer 10011. Thefoam layer 10011 is larger than the stabilizing structure 10013. Thestep or recess 10010 of the stabilizing clip fits around the larger foamlayer 10011. The step or recess 10010 may allow the stabilizing clip tosecure the stabilizing structure within the wound without applyingexcess pressure on the foam layer that is slightly larger than thestabilizing structure. The step or recess may be provided at anyvertical position along the attachment portion of the stabilizing clipto accommodate various depths of foams, stabilizing structures, and/orstabilizing clips.

FIGS. 27A-J illustrate an embodiment of stabilizing clip 11006, similarto the stabilizing clip of FIG. 23C. As with the other stabilizing clipembodiments illustrated in FIG. 23C, stabilizing clip 11006 may comprisean attachment portion 11002 that loops over the top of a wall of astabilizing structure and a securing portion 11004 that extends below alayer of tissue to maintain the stabilizing structure in place. Thestabilizing clip 11006, as illustrated in FIGS. 27A-J, may include afoot 11012 to latch to the bottom of the stabilizing structure 11013.The foot 11012 may be provided at the end 11014 of the loop of theattachment portion 11002 that loops over the top of a wall of thestabilizing structure 11004. The foot 11012 can provide strengthening inthe corner of the stabilizing clip 11006. The stabilizing clip 11006with the foot 11012 improves the stability and strength of thestabilizing clip 11006. FIGS. 27H-27J are pictures of the stabilizingclip 10006 attached to the stabilizing structure 10013. The stabilizingclip 11006 can include a foot and grippers as illustrated in someembodiments in FIGS. 25A-G.

FIGS. 28A-D are illustrations of embodiments of stabilizing clips 13000similar to the embodiments depicted in FIGS. 26A-26C. However, thestabilizing clips 13000 are wider than the clips depicted in FIGS.26A-26C. Stabilizing clip 13000 may comprise an attachment portion 13002that loops over the top of a wall of a stabilizing structure or may loopunderneath the wall of the stabilizing structure. The stabilizing clip13000 may also comprise a securing portion 13004 that extends below alayer of tissue such as the fascia, to maintain the stabilizingstructure in place. The securing portion 13004 may extend from a lowerend of the attachment portion 13002. The stabilizing clip 13000 caninclude a step or recess 13010 at the intersection of the securingportion 13004 and the attachment portion 13002 or where the securingportion 13004 extends horizontally from the attachment portion 13002.The securing portion 13004 may include grippers 13008 to assist inattaching the securing portion to the surrounding tissue. In otherembodiments, the stabilizing clip 13006 with the step or recess 13010may be used with a securing portion 13004 without grippers 13008 on thesurface of the securing portion 13004. The step 13010 can provide a stepor recess in the stabilizing clip to accommodate a foam and/or othermaterial positioned below the matrix, similar to the foam layersdescribed herein this section or elsewhere in the specification. Thestep 13010 allows the stabilizing clip 13006 attached to the matrixstabilizing structure to fit around a piece of foam that is placed belowthe stabilizing structure which may be slightly larger than thestabilizing structure. In some embodiments, the size of the step can bechanged to accommodate the various foam sizes.

FIG. 28D depicts an embodiment of stabilizing clip 13000 which comprisesa gap 13012 in the back of the stabilizing clip 13000. The gap allowsthe stabilizing clip 13000 to fit over an intersection or junction ofthe stabilizing structure, such as disclosed herein this section orelsewhere in the specification. By positioning the stabilizing clip overan intersection or junction within a stabilizing structure, the clip ismore resistant to lateral and other forces that may dislodge the clip.

FIG. 28E depicts an embodiment of a stabilizing clip 13000, similar tothe stabilizing clips of FIGS. 28A-D. Stabilizing clip 13000 of FIG. 28Efurther comprises a loop 13014 at the upper end of the stabilizing clip.This loop 13014 may be used to attach the clip to other components ofthe wound closure device, such as other clips via string or other means.Connecting clip 13000 to other clips may prevent the loss of clipswithin the wound.

FIGS. 29A-E depict embodiments of stabilizing clip 14000, similar to thestabilizing clips of FIGS. 23-28D, particularly the clip of FIG. 28C-D.AS illustrated in FIGS. 29A-B, stabilizer clip 14000 comprises anattachment portion 14002, tapered securing portion 14004, step 14010,grippers 14008, and gap 14012. The tapered securing portion of 14004comprises notch 14014. Similarly, the straight securing portion 14016 ofthe stabilizer clip 14000 of FIG. 29C-D comprises a notch 14014. FIG.29E depicts a stabilizer clip 14000 with a wide securing portion 14018.

FIGS. 30A-B depict stabilizing clips 15000 similar to the stabilizingclips of FIGS. 23A-29E. Much like the embodiments of the stabilizingclips disclosed above, stabilizing clip 15000 comprises an attachmentportion 15002, securing portion 15004, step 15010, and grippers 15008.However, stabilizing structure includes top hook 15012 and bottom hook15014, allowing the clip to be securely fastened to a stabilizingstructure such as those disclosed in FIGS. 2A-3E and 16-20F. Step 15010allows the stabilizing clip to fit over a layer of foam positioned underthe stabilizing structure.

FIG. 30B depicts an embodiment of a stabilizing clip 15000 furthercomprising pins 15016. These pins may be pressed securely into anunderlying foam layer to maintain both the foam and the clip inposition. In certain embodiments, the stabilizing clip may comprise,one, two, three, four, five or six individual pins. In some embodiments,the pin(s) may be located on other positions of the clip 15000, such asthe underside of securing portion 15004 or the top of the clip near tophook 15012.

FIGS. 31A-31H depict stabilizing clips similar to the stabilizer clipsof FIGS. 23A-30B, particularly the clip of FIGS. 28C-D. However, thestabilizing clips of FIGS. 31A-30H are linked together by linkers 14050.The linkers 14050 may be constructed from the same material as thestabilizing clips or any material disclosed herein this section orelsewhere in the specification. The linkers may be molded along with thestabilizer clips, 3D printed along with the stabilizer clips, orproduced by any other suitable means. The linkers serve to keep theclips together, thereby reducing the likelihood that a clip will be lostwithin the wound. In certain embodiments, the linkers may take the formof string or an adhesive. The stabilizing clips may be linked within along array including many stabilizing clips, which may be cut at thelinker position to create smaller groups of stabilizing clips such asdepicted in FIGS. 31C-D. In certain embodiments, and as depicted in FIG.30A, the stabilizing clips may be grouped together such that 1, 2, 3, 4,5 or more clips are closer together, followed by a wider gap 14002.

FIGS. 31G-31H depict embodiments of linked stabilizing clips linked byarches 14075. Further, FIG. 31H depicts stabilizing clips comprising anattachment portion 14004 with a short hook to loop over the top of astabilizing structure, combined with a gap 14080 to allow thestabilizing clips to be attached to an intersection within a stabilizingstructure.

FIG. 32A is a data table that tracks the collapse (as measured by adecrease in width) of an embodiment of a wound closure deviceincorporating stabilizing structures similar to the structures of FIGS.2A-3E and 16-20F, while the device is subjected to increasing levels ofvacuum. Here, foam was attached to the top and the bottom of astabilizing structure, similar to the embodiments of FIG. 20A-20F andentire device was placed within an animal model. The vacuum wasincreased from 40 mm Hg to 200 mm Hg. The pre vacuum width of the devicewas 123.4 mm, which decreased to 83.4 mm under vacuum. FIG. 32B displaysthe experimental data of FIG. 32A in the form of a bar graph.

As described above, a stabilizing structure such as those describedherein this section or elsewhere in the specification may be securingwithin a wound through the use of any stabilizing clip described hereinthis section or elsewhere in the specification. The following steps neednot be completed in any particularly order, but are provided in thefollowing order as an example. As depicted above in relation to FIGS.12A-C, the stabilizing structure may first be sized for a particularwound by trimming/removing portions of the stabilizing structure, or byproviding a stabilizing structure pre-made at a size appropriate for thewound. Upon sizing the stabilizing structure to a particular woundshape, stabilizing clips and/or foam may then be attached to thestabilizing structure. Then, the stabilizing structure is partiallyclosed so as to facilitate placing the stabilizing structure into anabdominal wound and securing the stabilizing clips and/or foam lip suchthat the clips and/or foam lip extend under the fascia layer. Since thefascia is a relative strong tissue, by securing the stabilizing clipsunderneath the fascia, the stabilizing structure cannot be pushed up ina direction out of the wound by the underlying viscera. As describedabove, any number of stabilizing clips may be used and they may extendabove and/or below various layers of tissue. Also, as described above,the stabilizing structures may come pre-made as various sizes, therebynegating the need to further trim or re-size the stabilizing structure.

In certain embodiments any of the stabilizing clips disclosed herein maybe combined with any of the anchoring layers or materials disclosedherein, such as those disclosed in FIGS. 4-6B. The anchoring materialmay be positioned on the face of the clip that faces the outside of thewound to provide additional attachment force to maintain the stabilizingstructure within the wound bed. In some embodiments, the stabilizingclips may comprise a velcro or gripping sidewall or sidewalls to allowthe clips to attach together to form a strip of clips. The anchoringlayers can be placed at any suitable location of the clip, such as thetop, bottom, front, back, or sides.

Various sensors may be placed within any of the stabilizing structuresor foam layers described herein this section or elsewhere in thespecification. For example, a pH, temperature, pressure sensor, or anyother suitable sensor may be embedded within the stabilizing structureand/or within a foam layer. Such embodiments will advantageously allow aclinician to skip the step of removing a sensor within the wound bed, asthe sensor simply be removed upon removal of the stabilizing structureor foam.

The stabilizer clips described herein this section or elsewhere in thespecification may be constructed via any suitable means. For example,the stabilizer clips may be 3D printed or molded separately from thestabilizing structures disclosed herein this section or elsewhere in thespecification. However, alternatively, the stabilizer clips may be 3Dprinted or molded directly attached to the stabilizing structure.

Although this disclosure describes certain embodiments, it will beunderstood by those skilled in the art that many aspects of the methodsand devices shown and described in the present disclosure may bedifferently combined and/or modified to form still further embodimentsor acceptable examples. All such modifications and variations areintended to be included herein within the scope of this disclosure.Indeed, a wide variety of designs and approaches are possible and arewithin the scope of this disclosure. No feature, structure, or stepdisclosed herein is essential or indispensable. Moreover, whileillustrative embodiments have been described herein, the scope of anyand all embodiments having equivalent elements, modifications,omissions, combinations (e.g., of aspects across various embodiments),substitutions, adaptations and/or alterations as would be appreciated bythose in the art based on the present disclosure. While certainembodiments have been described, these embodiments have been presentedby way of example only, and are not intended to limit the scope ofprotection.

Features, materials, characteristics, or groups described in conjunctionwith a particular aspect, embodiment, or example are to be understood tobe applicable to any other aspect, embodiment or example described inthis section or elsewhere in this specification unless incompatibletherewith. All of the features disclosed in this specification(including any accompanying claims, abstract and drawings), and/or allof the steps of any method or process so disclosed, may be combined inany combination, except combinations where at least some of suchfeatures and/or steps are mutually exclusive. The protection is notrestricted to the details of any foregoing embodiments. The protectionextends to any novel one, or any novel combination, of the featuresdisclosed in this specification (including any accompanying claims,abstract and drawings), or to any novel one, or any novel combination,of the steps of any method or process so disclosed.

Furthermore, certain features that are described in this disclosure inthe context of separate implementations can also be implemented incombination in a single implementation. Conversely, various featuresthat are described in the context of a single implementation can also beimplemented in multiple implementations separately or in any suitablesubcombination. Moreover, although features may be described above asacting in certain combinations, one or more features from a claimedcombination can, in some cases, be excised from the combination, and thecombination may be claimed as a subcombination or variation of asubcombination.

Moreover, while operations may be depicted in the drawings or describedin the specification in a particular order, such operations need not beperformed in the particular order shown or in sequential order, or thatall operations be performed, to achieve desirable results. Otheroperations that are not depicted or described can be incorporated in theexample methods and processes. For example, one or more additionaloperations can be performed before, after, simultaneously, or betweenany of the described operations. Further, the operations may berearranged or reordered in other implementations. Those skilled in theart will appreciate that in some embodiments, the actual steps taken inthe processes illustrated and/or disclosed may differ from those shownin the figures. Depending on the embodiment, certain of the stepsdescribed above may be removed, others may be added. Furthermore, thefeatures and attributes of the specific embodiments disclosed above maybe combined in different ways to form additional embodiments, all ofwhich fall within the scope of the present disclosure. Also, theseparation of various system components in the implementations describedabove should not be understood as requiring such separation in allimplementations, and it should be understood that the describedcomponents and systems can generally be integrated together in a singleproduct or packaged into multiple products.

For purposes of this disclosure, certain aspects, advantages, and novelfeatures are described herein. Not necessarily all such advantages maybe achieved in accordance with any particular embodiment. Thus, forexample, those skilled in the art will recognize that the disclosure maybe embodied or carried out in a manner that achieves one advantage or agroup of advantages as taught herein without necessarily achieving otheradvantages as may be taught or suggested herein.

Conditional language, such as “can,” “could,” “might,” or “may,” unlessspecifically stated otherwise, or otherwise understood within thecontext as used, is generally intended to convey that certainembodiments include, while other embodiments do not include, certainfeatures, elements, and/or steps. Thus, such conditional language is notgenerally intended to imply that features, elements, and/or steps are inany way required for one or more embodiments or that one or moreembodiments necessarily include logic for deciding, with or without userinput or prompting, whether these features, elements, and/or steps areincluded or are to be performed in any particular embodiment.

Conjunctive language such as the phrase “at least one of X, Y, and Z,”unless specifically stated otherwise, is otherwise understood with thecontext as used in general to convey that an item, term, etc. may beeither X, Y, or Z. Thus, such conjunctive language is not generallyintended to imply that certain embodiments require the presence of atleast one of X, at least one of Y, and at least one of Z.

Language of degree used herein, such as the terms “approximately,”“about,” “generally,” and “substantially” as used herein represent avalue, amount, or characteristic close to the stated value, amount, orcharacteristic that still performs a desired function or achieves adesired result. For example, the terms “approximately”, “about”,“generally,” and “substantially” may refer to an amount that is withinless than 10% of, within less than 5% of, within less than 1% of, withinless than 0.1% of, and within less than 0.01% of the stated amount. Asanother example, in certain embodiments, the terms “generally parallel”and “substantially parallel” refer to a value, amount, or characteristicthat departs from exactly parallel by less than or equal to 15 degrees,10 degrees, 5 degrees, 3 degrees, 1 degree, 0.1 degree, or otherwise.

The scope of the present disclosure is not intended to be limited by thespecific disclosures of preferred embodiments in this section orelsewhere in this specification, and may be defined by claims aspresented in this section or elsewhere in this specification or aspresented in the future. The language of the claims is to be interpretedbroadly based on the language employed in the claims and not limited tothe examples described in the present specification or during theprosecution of the application, which examples are to be construed asnon-exclusive.

What is claimed is:
 1. An apparatus for treating a wound with negativepressure wound therapy, comprising: a stabilizing structure having anoculiform shape for insertion into a wound and comprising a firstplurality of cells along a central transverse axis, the stabilizingstructure configured to collapse more in a horizontal plane parallel toa length and a width of the stabilizing structure than in a verticalplane perpendicular to the horizontal plane; wherein the stabilizingstructure comprises two extended sections extending in oppositedirections from the central transverse axis and along a longitudinalaxis extending along opposite ends of the stabilizing structure, theextended sections each comprising a further plurality of cells in rowsin a transverse direction wherein the rows in each extended section havefewer cells along a transverse direction than the first plurality ofcells along the central transverse axis and wherein each extendedsection includes at least two cells that extend along the longitudinalaxis at the opposite ends of the stabilizing structure; and wherein thestabilizing structure comprises curved outer walls on opposite sides ofthe longitudinal axis defining a perimeter, wherein the curved outerwalls converge at the extended sections such that the extended sectionsextend beyond an outer edge of a virtual ellipse formed by a majority ofthe perimeter along the longitudinal axis of the stabilizing structure.2. The apparatus of claim 1, wherein the extended sections comprise astepped shaped.
 3. The apparatus of claim 1, wherein the extendedsections comprise a first row comprising four cells, a second rowcomprising two cells, and a third row comprising two cells.
 4. Theapparatus of claim 1, further comprising a plurality of tabs extendingoutward from the perimeter of the stabilizing structure.
 5. Theapparatus of claim 4, wherein the tabs comprise anchors configured togrip foam.
 6. The apparatus of claim 1, further comprising a firstbottom layer of foam attached to a bottom of the stabilizing structure.7. The apparatus of claim 6, wherein the first bottom layer of foamcomprises a lip that extends outward to extend into surrounding tissue.8. The apparatus of claim 1, further comprising a top layer of foamattached to a top of the stabilizing structure.
 9. The apparatus ofclaim 6, further comprising a second bottom layer of foam attached tothe first bottom layer of foam.
 10. The apparatus of claim 9, whereinthe second bottom layer of foam comprises a lip that extends outwardfrom the stabilizing structure for positioning beneath a fascia layer.11. The apparatus of claim 6, wherein the first bottom layer of foam isattached to a plurality of tabs extending from the perimeter of thestabilizing structure.
 12. The apparatus of claim 11, wherein the firstbottom layer of foam comprises printed symbols, the symbols comprisingarrows indicating the proper positioning of the foam layer within thewound.
 13. The apparatus of claim 1, wherein each cell in the firstplurality of cells comprises a length and a width, the lengths of atleast some of the cells becoming progressively longer along thelongitudinal axis of the stabilizing structure toward the centraltransverse axis of the stabilizing structure.
 14. The apparatus of claim1, wherein cells in the first plurality of cells along the centraltransverse axis of the stabilizing structure are larger than cells inthe further plurality of cells near a longitudinal edge of thestabilizing structure.
 15. The apparatus of claim 1, wherein cells inthe first plurality of cells near the center of the stabilizingstructure are larger than cells in the further plurality of cells near alongitudinal edge of the stabilizing structure.
 16. The apparatus ofclaim 1, wherein the first plurality of cells along the centraltransverse axis and the further plurality of cells in the extendedsections have different sizes.
 17. The apparatus of claim 1, wherein thecells of the extended sections are configured to avoid collapse uponapplication of negative pressure to the stabilizing structure.